In India, In -Vitro Diagnostic kits/reagents are regulated under the provisions of the Medical Device Rules, 2017.
IVD’s are defined as substances intended to be used outside human or animal bodies for the diagnosis of any disease or disorder in human beings or animals covered under sub-clause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and IVDs that are notified, from time to time, as a device under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940.
Important Notes:
- IVD products which are currently registered in India have to be registered according to the provisions of Medical Device Rules 2017.
- Instruments, equipment and software used with IVDs are not be covered in Medical Device Rules 2017.
- Since IVD’s are interventional and put into systemic circulation in living bodies, all principles and norms applicable for regulations of chemical, biological and radiological drugs shall also be applicable in such products.
- In – Vitro Diagnostic devices for HBsAg, HIV and HCV manufactured / Imported under valid license issued by the CLA or SLA, may also be used in Blood Bank, as the criteria like Sensitivity (%) and Specificity (%) for evaluation of the HBsAg, HIV and HCV diagnostic kits for the Transfusion purpose (Blood Banks) and Diagnostic purpose are same, Provided the manufacturer claims in the product labels or in the IFU that the product is intended both the purposes; for blood screening and diagnostic.
- Both shelf life or expiry date and date of manufacture shall require on the labels.
Licensing Authority:
Central Licensing Authority: Enforcement of rules in matters related to:
- Import of all Classes of IVDs.
- Manufacture of Class C and Class D IVDs.
- Clinical performance evaluation and approval of new in vitro diagnostic.
- Registration of Notified Bodies
- Registration of Laboratories for carrying out test or evaluation.
- Test licences for manufacture or import of all classes of IVDs
State Licensing Authority: Enforcement of rules in matters related to:
- Manufacture for sale or distribution of Class A or Class B IVD
- Sale, stock, exhibit or offer for sale or distribution of IVDs of all classes.
Classification of IVD:
(i) low risk – Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.
Fees required to be paid along with the application for grant of import licence for IVDs:
| For each distinct Class-A, Class B, Class C ad Class D IVDs: Category | Product Fees (USD) | manufacturing site (USD) |
| Class-A | 10 | 1000 |
| Class-B | 10 | 1000 |
| Class-C | 500 | 3000 |
| Class-D | 500 | 3000 |
List of In Vitro Diagnostics Medical Devices under provisions of sub-rule (2) rule 4 of the medical devices rules 2017
(i) Class B In Vitro Diagnostics Medical Devices:
| S. No. | Category | In vitro diagnostic medical device |
Risk Class | Intended use |
| 1 | Clinical Chemistry Reagents/Kits for estimation of various Parameters exemplified as:
|
Acid Phosphatase (total or prostatic) test reagents/kits | Class B | An acid phosphatase (total or prostatic) test reagent/kit is a medical device, intended for the estimation of acid phosphatase in serum/plasma. |
| 2 | Albumin test reagents/kits | Class B | An albumin test reagent/kit is a medical device intended for the estimation of albumin in serum/plasma. | |
| 3 | Alkaline phosphatase or isoenzymes test reagents/kits | Class B | An alkaline phosphatase or isoenzymes test reagent/kit is a medical device intended for the estimation of alkaline phosphatase or its isoenzymes in serum/plasma. | |
| 4 | Ammonia test reagents/kits | Class B | An ammonia test reagent/kit is a medical device intended for the estimation of ammonia levels in blood, serum /plasma. | |
| 5 | Amylase test reagents/kits | Class B | An amylase test reagent/kit is a medical device intended for the estimation of the enzyme amylase in serum, saliva / urine. | |
| 6 | Bicarbonate / carbon dioxide test reagents/kits | Class B | A bicarbonate/carbon dioxide test reagent/kit s a medical device for the estimation of bicarbonate /carbon dioxide in plasma, serum/whole blood. | |
| 7 | bilirubin (total and direct) test reagents/kits | Class B | A bilirubin (total and direct) test reagent/kit is a medical device intended for the estimation of bilirubin (total and direct) in serum/plasma. | |
| 8 | Calcium test reagents/kits | Class B | A calcium test reagent/kit is a medical device intended for the estimation of total calcium in serum. | |
| 9 | Chloride test reagents/kits | Class B | A chloride test reagent/kit is a medical device intended for the estimation of chloride in plasma, serum, sweat /urine. | |
| 10 | cholesterol (total) test reagents/kits | Class B | A cholesterol (total) test reagent/kit is a medical device intended for the estimation of cholesterol in serum or plasma. | |
| 11 | HDL cholesterol test reagents /kits | Class B | A HDL cholesterol test reagent/kit is a medical device intended for the estimation of HDL cholesterol in serum / plasma. | |
| 12 | LDL cholesterol test reagents /kits | Class B | A LDL cholesterol test reagent/kit is a medical device intended for the estimation of LDL cholesterol in serum/plasma. | |
| 13 | Lipoproteinstest reagents /kits | Class B | A lipoprotein test reagent/kit is a medical device intended for the estimation of lipoproteins in serum / plasma. | |
| 14 | Cholinesterase test reagents /kits | Class B | A cholinesterase test reagent/kit is a medical device intended for the estimation of cholinesteral in serum/plasma. | |
| 15 | Creatine Kinase and its isoenzymestest reagents/kits |
Class B | A creatine phosphokinase/creatine kinase or isoenzymes including CKMB, CKBB and CKMM test reagent/kit is a medical device intended for the estimation of the enzyme creatine phosphokinase or its isoenzymes in serum / plasma. | |
| 16 | Copper test reagents/kits | Class B | Copper test reagent/kit is a medical device intended for the estimation of copper in plasma, serum / urine. | |
| 17 | Creatinine test reagents/kits | Class B | A creatinine test reagent/kit is a medical device intended for the estimation of creatinine in serum, plasma / urine. | |
| 18 | Gamma Glutamyl Transferase (GGT) and isoenymes test reagents /kits | Class B | A Gamma Glutamyl Transferase (GGT) and isoenzymes test reagent/kit is a medical device intended for the estimation of the enzyme Gamma GlutamylTransferase (GGT) in serum / plasma. | |
| 19 | Glucose test reagents/kits | Class B | A Glucose test reagent/kit is a medical device intended for the estimation of glucose in blood/plasma/ body fluids. | |
| 20 | Glucose-6-Phosphate Dehydrogenase (G6PD) and its isoenzymes test reagents/kits. |
Class B | A Glucose-6 Phosphate Dehydrogenase(G6PD)test reagents/kit is a medical device intended for the estimation of Glucose-6-Phosphate Dehydrogenase or its isoenzymes in serum / plasma. |
|
| 21 | Glycosylated Hemoglobin or its variants test reagents/kits | Class B | Glycosylated Hemoglobin or its variants test reagents/kits are medical devices intended for the estimation of glycosylated hemoglobin or its variants including A1a, A1b, and A1c in blood. | |
| 22 | Hemoglobin test reagents /kits | Class B | A hemoglobin test reagent/kit is a medical device intended for the estimation of hemoglobin in blood. | |
| 23 | Iron test reagents/kits | Class B | An iron test reagent/kit is a medical device intended for the estimation of iron in serum /plasma. | |
| 25 | Iron-binding capacity test reagents /kits |
Class B | Iron-binding capacity test reagents/kits are medical devices intended for the estimation of iron-binding capacity in serum / plasma. | |
| 26 | Lactate Dehydrogenase and its isoenzymes test reagents /kits | Class B | A Lactate Dehydrogenase and its isoenzymes test reagent/kit is a medical device intended for the estimation of enzyme Lactate Dehydrogenase and its isoenzymes in serum / plasma. | |
| 27 | Lipase test reagents/kits | Class B | A lipase test reagent/kit is a medical device intended for the estimation of lipase in serum / plasma. | |
| 28 | Magnesium test reagents /kits | Class B | A magnesium test reagent/kit is a medical device intended for the estimation of magnesium levels in serum / plasma | |
| 29 | Phosphorus (inorganic) test reagents /kits | Class B | A phosphorus (inorganic) test reagent/kit is a medical device intended for the estimation of inorganic phosphorus in serum, plasma / urine. | |
| 30 | Potassium test reagents/kits | Class B | A potassium test reagent/kit is a medical device intended for the estimation of potassium in serum, plasma / urine. | |
| 31 | Aspartate Amino Transferase (AST/SGOT) test reagents /kits |
Class B | An Aspartate Amino Transferase (AST/SGOT) test reagent/kit is a medical device intended for the estimation of the enzyme Aspartate Amino Transferase (AST/SGOT) in serum / plasma. | |
| 32 | Alanine Amino Transferase (ALT/SGPT) test reagents /kits |
Class B | An Alanine Amino Transferase (ALT/SGPT) test reagent/kit is a medical device intended for the estimation of enzyme Alanine Amino Transferase (ALT/SGPT) in serum / plasma. | |
| 33 | Sodium test reagents/kits | Class B | A Sodium test reagent/kit is a medical device intended for the estimation of sodium in serum/ plasma / urine. | |
| 34 | Total protein test reagents /kits | Class B | A Total Protein test reagent/kit is a medical device intended for the estimation of total protein(s) in serum / plasma. | |
| 35 | Protein (fractionation) test reagents /kits | Class B | A Protein (fractionation) test reagent/kit is a medical device intended for the estimation of protein fractions in blood, urine, cerebrospinal fluid / other body fluids. |
|
| 36 | Protein-bound iodine test reagents /kits | Class B | A Protein-bound iodine test reagent/kit is a medical device intended for the estimation of protein-bound iodine in serum /plasma. | |
| 37 | Triglycerides test reagents /kits | Class B | A Triglyceride test reagent/kit is a medical device intended for the estimation of triglycerides in serum /plasma. | |
| 38 | Urea (BUN) test reagents /kits | Class B | A Urea (BUN) test reagent/kit is a medical device intended for the estimation of urea/Blood Urea Nitrogen (BUN) in plasma/ serum /urine. | |
| 39 | Uric Acid test reagents/kits | Class B | A Uric Acid test reagent/kit is a medical device intended for the estimation of uric acid in serum/plasma / urine. | |
| 40 | Micro-Protein test reagents /kits | Class B | A Micro-protein test reagent/kit is a medical device intended for the estimation of micro-proteins including micro-albumin in urine. | |
| 41 | Zinc test reagents/kits | Class B | A Zinc test reagent/kit is a medical device intended for the estimation of zinc in serum / plasma. | |
| 42 | Other clinical chemistry test reagents/kits | Class B | Clinical chemistry test reagent/kit intended for the estimation of analytes/ parameters (other than listedabove) in serum/ plasma/ urine or other body fluids. | |
| 43 | Hematology Reagents/Kits for estimation of Complete Blood Counts , exemplified as: | Blood cell Diluents | Class B | A blood cell Diluent is a medical device used to dilute blood for further testing, such as Complete Blood Count(CBC). |
| 44 | Lyse reagents/kits for differential counts | Class B | A Lyse reagent/kit is a medical device used for lysing of cells for the estimation of Complete Blood Count(CBC). | |
| 45 | Rinse/Detergent/Cleaners reagents/kits | Class B | A Rinse/Detergent/Cleaner reagent/kit is a medical device used for cleaning various parts of Hematology analyzers like probes, needles, baths, tubing etc. | |
| 46 | Reagents/Kits for estimation of parameters in the urine, exemplified as: | Ascorbic Acid/ Bilirubin /Blood Cells/Glucose/ Ketone / Leukocyte peroxidase / Specific gravity/Urobilinogen Nitrite / pH / Protein /Albumin & other urinary analytes test reagents /Strips/kits | Class B | Ascorbic Acid/ Bilirubin /Blood Cells/Glucose/ Ketone / Leukocyte peroxidase / Specific gravity/Urobilinogen Nitrite / pH / Protein / Albumin & other urinary analytes test reagents /Strips/kits, are medical devices intended for the preliminary estimation of diagnostic markers in urine |
| 47 | In – vitro 47. Diagnostic Medical Devices for Self -Testing
|
Glucose test reagents/kits | Class B | A glucose test reagent/kit is a medical device intended for the preliminary self testing of glucose levels in blood /body fluids. |
| 48 | Human Chorionic Gonadotropin (hCG) test reagents/kits | Class B | A human Chorionic Gonadotropin (hCG) test reagent/kit is a medical device intended for the preliminary self testing of hCG in urine/body fluids. | |
| 49 | Luteinizing Hormone (LH) test reagents/kits | Class B | A Luteinizing Hormone (LH) test reagent/kit is a medical device intended for the preliminary self testing of Luteinizing Hormone (LH) in urine/body fluids. | |
| 50 | Glycosylated hemoglobinor its variants Test reagents /kits | Class B | Glycosylated Hemoglobin or its variants test reagents/kits are medical devices intended for the preliminary self testing of Glycosylated Hemoglobin or its variants including A1a, A1b, and A1c in blood. | |
| 51 | Cholesterol test reagents /kits | Class B | A Cholesterol test reagent/kit is a medical device intended for preliminary self testing of cholesterol in blood /body fluids. | |
| 52 | Follicle Stimulating Hormone (FSH) test reagents /kits | Class B | A Follicle Stimulating Hormone (FSH) test reagent/kit is a medical device intended for the preliminaryself testing of Follicle Stimulating Hormone (FSH) in urine /body fluids | |
| 53 | Other In – vitro Diagnostic Medical Devices for Self – Testing |
Class B | ||
| 54 | Reagents/ Kits for detection of autoimmune disorders exemplified as:
|
Anti Nuclear Antibodies test reagents/kits | Class B | Anti Nuclear Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to nuclear antigens in human specimens. |
| 55 | Anti Transglutaminase Antibodies test reagents /kits | Class B | Anti Transglutaminase Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to Transglutaminase in human specimens. | |
| 56 | Anti Ganglioside Antibodies test reagents/kits | Class B | Anti Ganglioside Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to Ganglioside in human specimens. | |
| 57 | Anti-Cyclic Citrullinated Peptide (CCP) Antibodies test reagents/kits | Class B | Anti CyclicCitrullinated Peptide (CCP) Antibodies test reagent/kit is a medical device for the screening of CCP auto-antibodies in human specimens. | |
| 58 | Rheumatoid Factor (RF) immunological test reagents /kits | Class B | Rheumatoid Factor (RF) immunological test reagent/kit is a medical device for the screening of Rheumatoid Factor in human specimens. | |
| 59 | Anti Smooth Muscle Antibody test reagents/kits | Class B | Anti Smooth Muscle Antibody test reagent/kit is a medical device for the screening of auto-antibodies to smooth muscles in human specimens. | |
| 60 | Glutamic Acid Decarboxylase (GAD) Antibody test reagents /kits | Class B | Glutamic Acid Decarboxylase (GAD) Antibodytest reagent/kit is a medical device for the screening of auto- antibodies to Glutamic Acid Decarboxylase (in human specimens. | |
| 61 | Anti ovary antibodies test reagents/kits | Class B | Anti ovary antibodies test reagent/kit is a medical device for the screening of auto-antibodies to ovarian antigens in human specimens | |
| 62 | Anti sperm Antibodies test reagents/kits |
Class B | Anti sperm antibodies test reagent/kit is a medical device for the screening of auto-antibodies to spermatozoa in human specimens. | |
| 63 | Anti-IA2 test reagents/kits | Class B | Anti IA-2 antibodies test reagent/kit is a medical device for the screening of auto-antibodies to IA-2 (tyrosine phosphatase) in human specimens. | |
| 64 | Anti-Acetylcholine Receptor test reagents/kits. | Class B | Anti-Acetylcholine Receptor test reagent/kit is a medical device for the screening of auto-antibodies to Acetylcholine Receptor in human specimens. | |
| 65 | Anti Thyroid gland antibody test reagents/kits. | Class B | Anti Thyroid gland antibodies test reagent/kit is a medical device for the screening of auto-antibodies to thyroid gland antigens in human specimens. | |
| 66 | ANCA test reagents/kits | Class B | The ANCA test reagent/kit is a medical device for the screening of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) in human specimens. | |
| 64 | Anti-double stranded DNA (anti-dsDNA) test reagents /kits | Class B | The Anti-double stranded DNA (Anti-dsDNA) test reagent/kit is a medical device for the screening of auto-antibodies to Double stranded DNA in human specimens. | |
| 65 | Anti-Extractable Nuclear Antigen(Anti- ENA)test reagents /kits. | Class B | The Anti-Extractable Nuclear Antigen(Anti-ENA)test reagent/kit is a medical device for the screening of auto-antibodies to Extractable Nuclear Antigens like Smith (Sm) Antigens, Ribonuclears Protein (RNP), anti SSA (Ro) etc. in human specimens. | |
| 66 | Anti-Intrinsic Factor test reagents /kits | Class B | The Anti-Intrinsic Factor test reagent/kit is a medical device for the screening of antibodies against intrinsic factor in human specimens. | |
| 67 | Anti-Saccharomyces Cerevisiae Antibodies (ASCA) test reagents/kits | Class B | The Anti-Saccharomyces Cerevisiae Antibodies (ASCA) test reagent/kit is a medical device for the screening of antibodies against Saccharomyces Cerevisiae in human specimens. | |
| 68 | Other Reagents/ Kits for detection of autoimmune disorders | Class B | ||
| 69 | Reagents/ Kits for detection of Cardiac Markers exemplified as under | Creatine Kinase (CK) and CKMB test reagents/kits | Class B | Creatine Kinase (CK) and CKMB test reagent/kit are medical devices intended for the estimation of Creatine Kinase (CK) and CKMB in blood / body fluids. |
| 70 | Myoglobin test reagents /kits | Class B | Myglobin Test reagent/kit for is a medical device intended for the estimation of myglobin in blood /body fluids. | |
| 71 | Reagents/ Kits for the detection of Antibodies to infectious agents with a risk of limited propagation exemplified as under:
|
Malaria Antibody test reagents and kits | Class B | Malaria Antibody test reagent/kit is a medical device intended for the detection of Malaria Antibody in blood/body fluids |
| 72 | Dengue Antibody test reagents and kits | Class B | Dengue Antibody test reagent/kit is a medical device intended for the detection of Dengue Antibody in blood/body fluids. | |
| 73 | Chikungunya Antibody test reagents and kits | Class B | Chikungunya Antibody test reagent/kit is a medical device intended for the detection of Chikungunya Antibody in blood/body fluids. | |
| 74 | Leptospira Antibody test reagents and kits | Class B | Leptospira Antibody test reagent/kit is a medical device intended for the detection of Leptospira Antibody in blood /body fluids | |
| 75 | Japanese Encephalitis Antibody test reagents and kits | Class B | Japanese Encephalitis Antibody test reagent/kit is a medical device intended for the detection of Japanese Encephalitis Antibody in blood/body fluids. | |
| 76 | Typhoid Antibody test reagents and kits | Class B | Typhoid Antibody test reagent/kit is a medical device intended for the detection of Typhoid Antibody in blood/body fluids | |
| 77 | Cryptococcus neoformans Antibody test reagents and kits | Class B | Cryptococcus neoformans Antibody test reagent/kit is a medical device intended for the detection Cryptococcus neoformans Antibody in blood/body fluids. | |
| 78 | Neisseria meningitides Antibody test reagents and kits. | Class B | Neisseria meningitides Antibody test reagent/kit is a medical device intended for the detection of Neisseria meningitides Antibody in blood/body fluids | |
| 79 | Vibrio cholera Antibody test reagents and kits | Class B | Vibrio cholera Antibody test reagent/kit is a medical device intended for the detection of Vibrio cholera Antibody in blood/body fluids | |
| 80 | Influenza A Antibody test reagents and kits | Class B | Influenza A Antibody test reagent/kit is a medical device intended for the detection of Influenza A Antibody in blood/body fluids |
|
| 81 | Influenza B Antibody test reagents and kits | Class B | Influenza B Antibody test reagent/kit is a medical device intended for the detection of Influenza B Antibody in blood /body fluids. | |
| 82 | Strep A Antibody test reagents and kits | Class B | Strep A Antibody test reagent/kit is a medical device intended for the detection of Strep A Antibody in blood/body fluids | |
| 83 | Strep B Antibody test reagents and kits | Class B | Strep B Antibody test reagents/kits is a medical device intended for the detection of Strep B Antibody in blood/body fluids | |
| 84 | Chagas Antibody test reagents and kits | Class B | Chagas Antibody test reagent/kit is a medical device intended for the detection of Chagas Antibody in blood/body fluids | |
| 85 | Filariasis Antibody test reagents and kits | Class B | Filariasis Antibody test reagent/kit is a medical device intended for the detection of Filariasis Antibody in blood/body fluids. | |
| 86 | Kala Azar Antibody test reagents and kits | Class B | Kala Azar Antibody test reagents/kits is a medical device intended for the detection of Kala Azar Antibody in blood /body fluids | |
| 87 | Rotavirus Antibody test reagents and kits | Class B | Rotavirus Antibody test reagents/kits is a medical device intended for thedetection of Rotavirus Antibody in blood /body fluids | |
| 88 | S. pneumonia Antibody test reagents and kits. | Class B | S. pneumonia Antibody test reagent/kit is a medical device intended for the detection of S. pneumonia Antibody in blood/body fluids. | |
| 89 | H. pylori Antibody test reagents and kits | Class B | H.pylori Antibody test reagent/kit is a medical device intended for the detection of H.pylori Antibody in blood/body fluids | |
| 90 | Other Reagents/ Kits for the detection of Antibodies to infectious agents with a risk of limited propagation | Class B | ||
| 91 | Other in vitro Medical Devices
|
TSH test reagents/kits | Class B | TSH test reagent/kit is a medical device intended for the estimation TSH in blood/body fluids. |
| 92 | Total /Free triiodothyronine (T3) test reagents/kits | Class B | Total /Free triiodothyronine (T3) test reagent/kit is a medical device intended for the estimation Total /Free triiodothyronine (T3) in blood/body fluids | |
| 93 | Total / Free thyroxine (T4) test reagents/kits | Class B | Total / Free thyroxine (T4)test reagent/kit is a medical device intended for the estimation of Total / Free thyroxine (T4)in blood/body fluids. | |
| 94 | Dehydroepiandrosterone (DHEA-S) (free and sulfate) test reagents/kits | Class B | Dehydroepiandrosterone (DHEA-S) (free and sulfate) test reagent/kit is a medical device intended for the estimation of DHEA-S (free sulfate) in blood/body fluids | |
| 95 | Estrogen test reagents/kits | Class B | Estrogen test reagent/kit is a medical device intended for the estimation of Estrogen in blood/body fluids | |
| 96 | Progesterone test reagents /kits | Class B | Progesterone test reagent/kit is a medical device intended for the estimation of Progesterone in blood/body fluids | |
| 97 | Testosterone (Free and Total) test reagents/kits | Class B | Testosterone (Free and Total) test reagent/kit is a medical device intended for the estimation of Testosterone (Free and Total) in blood/body fluids. | |
| 98 | Sex Hormone Binding Globulin (SHBG) test reagents /kits | Class B | Sex Hormone Binding Globulin (SHBG) test reagent/kit is a medical device intended for the estimation of Sex Hormone Binding Globulin (SHBG) in blood/body fluids | |
| 99 | Cortisol test reagents/kits | Class B | Cortisol test reagent/kit is a medical device intended for the estimation of Cortisol in blood/body fluids | |
| 100 | Insulin test reagents/kits | Class B | Insulin test reagent/kit is a medical device intended for the estimation of Insulin in blood/body fluids | |
| 101 | Luteinizing Hormone(LH) test reagents/kits | Class B | Luteinizing Hormones (LH )test reagent/kit is a medical device intended for the estimation of Luteinizing Hormone (LH) in blood/body fluids. | |
| 102 | Follicle Stimulating Hormone (FSH) test reagents /kits | Class B | Follicle Stimulating Hormone (FSH) test reagent/kit is a medical device intended for the estimation of Follicle Stimulating Hormone(FSH) in blood/body fluids. | |
| 103 | Prolactin test reagents/kits | Class B | Prolactin test reagent/kit is a medical device intended for the estimation of Prolactin in blood/body fluids | |
| 104 | Other test reagents/kits for hormones | Class B | Test reagents/kits for the estimation of other than above hormones in blood/body fluids | |
| 105 | Vitamin B test reagents /kits | Class B | Vitamin B test reagent/kit is a medical device intended for the estimation of Vitamin B in blood/body fluids | |
| 106 | Vitamin D test reagents /kits | Class B | Vitamin D test reagent/kit is a medical device intended for the estimation of Vitamin B in blood/body fluids | |
| 107 | Vitamin A test reagents/kits | Class B | Vitamin A test reagent/kit is a medical device intended for the estimation of Vitamin A in blood/body fluids | |
| 108 | Vitamin E test reagents /kits | Class B | Vitamin E test reagent/kit is a medical device intended for the estimation of Vitamin E in blood/body fluids | |
| 109 | Vitamin K test reagents /kits | Class B | Vitamin K test reagent/kit is a medical device intended for the estimation of Vitamin K in blood/body fluids |
(ii) Class C In Vitro Diagnostics Medical Devices:
| S. No. | Category | In vitro diagnostic medical device |
Risk Class | Intended use |
| 1 | In – vitro Diagnostic Medical Device for near patient testing.
|
Blood Gas Analysis test reagents /kits | Class C | A Blood Gas Analysis test reagent/kit for near patient testing, is a medical device intended for the estimation of certain gases (such as oxygen and carbon dioxide etc.) dissolved in arterial blood. |
| 2 | Anticoagulant monitoring test reagents/kits | Class C | An Anticoagulant monitoring test reagent/kit for near patient testing, is a medical device intended for the estimation of coagulation parameters (such as PT, TT, APTT etc.) in plasma/blood. | |
| 3 | Diabetes management test reagents/kits | Class C | A Diabetes management test reagent/kit for near patient testing, is a medical device intended for the of monitoring of diabetes in body fluids. | |
| 4 | C- Reactive Protein (CRP)test reagents/kits | Class C | A C- Reactive Protein (CRP) test reagent/kit for near patient testing, is a medical device intended for the estimation of C -Reactive Protein (CRP) in serum and other body fluids. | |
| 5 | H. pylori test reagents/kits | Class C | An H. pylori test reagent/kit for near patient testing, is a medical device intended for the estimation of H. pylori in blood/body fluids. | |
| 6 | Troponin test reagents/kits | Class C | A Troponin test reagent/kit for near patient testing, is a medical device intended for the estimation of Troponin T,I and its variants in blood/body fluids | |
| 7 | Other in vitro Diagnostic Medical Devices for near patient test reagents/kits | Class C | In vitro Diagnostic Medical Device for near patient test reagent/kit intended for the estimation of analytes/ parameters (other than listed above) in serum, plasma, urine or other body fluids. | |
| 8 | Reagents/Kits for estimation of parameters of ToRCH& other infectious agents exemplified as under:
|
Toxoplasma gondii test reagents /kits | Class C | A Toxoplasma gondii test reagent/kit is a medical device intended for the detection of Toxoplasma gondii in serum /body fluids. |
| 9 | Rubella virus l test reagents /kits | Class C | A Rubella virus test reagent/kit is a medical device intended for the detection of Rubella virus in serum/body fluids. | |
| 10 | Cytomegalovirus test reagents /kits | Class C | A Cytomegalovirus test reagent/kit is a medical device intended for the detection of Cytomegalovirus in serum/body fluids. | |
| 11 | Herpes simplex virus reagents /kits | Class C | A Herpes simplex virus test reagent/kit is a medical device intended for the detection of Herpes simplex virus in serum /body fluids. | |
| 12 | Chlamydia pneumoniae test reagents/kits | Class C | A Chlamydia pneumoniae test reagent/kit is a medical device intended for the detection of Chlamydia pneumonia in serum/body fluids. | |
| 13 | Methicillin-Resistant Staphylococcus aureus test reagents/kits | Class C | A Methicillin-Resistant Staphylococcus aureus test reagent/kit is a medical device intended for the detection of Methicillin-ResistantStaphylococcus aureus in serum/body fluids | |
| 14 | Enterovirus test reagents /kits | Class C | An Enterovirus test reagent/kit is a medical device intended for the detection of enterovirus) in serum/body fluids. | |
| 15 | Reagents/Kits for detection of Cancer Markers exemplified as :
|
Alpha-fetoprotein test reagents /kits |
Class C | An Alpha-fetoprotein test reagent/kit is a medical device intended for the detection of Alpha-fetoprotein in serum /body fluids. |
| 16 | Beta-2 microglobulin test reagents /kits | Class C | A Beta-2 microglobulin test reagent/kit is a medical device intended for the detection of Beta-2 microglobulin in serum /body fluids | |
| 17 | Bladder tumour antigen (BTA) test reagents/kits | Class C | A Bladder tumour antigen (BTA) test reagent/kit is a medical device intended for the detection of Bladder tumour antigen (BTA)in serum/body fluids | |
| 18 | CA15-3 test reagents /kits | Class C | A CA15-3 antigen (BTA) test reagent/kit is a medical device intended for the detection of CA15-3 in serum/body fluids | |
| 19 | CA27.29 test reagents/kits | Class C | A CA27.29 test reagent/kit is a medical device intended for the detection of CA27.29 in serum/body fluids | |
| 20 | CA125 test reagents/kits | Class C | A CA125test reagent/kit is a medical device intended for the detection of CA125 in serum/body fluids | |
| 21 | CA72-4 test reagents/kits | Class C | A CA72-4 test reagent/kit is a medical device intended for the detection of CA72-4 in serum/body fluids | |
| 22 | CA19-9 test reagents/kits | Class C | A CA19-9 test reagent/kit is a medical device intended for the detection of CA19-9 in serum/body fluids | |
| 23 | Calcitonin test reagents /kits | Class C | A Calcitonin test reagent/kit is a medical device intended for the detection of Calcitonin in serum/body fluids | |
| 24 | Carcinoembryonic antigen (CEA) test reagents/kits | Class C | A Carcinoembryonic antigen (CEA) test reagent/kit is a medical device intended for the detection of Carcinoembryonic antigen (CEA) in serum/body fluids | |
| 25 | Chromogranin A testreagents /kits | Class C | A Chromogranin A test reagent/kit is a medical device intended for the detection of Chromogranin A in serum/body fluids | |
| 26 | Estrogen / Progesterone receptors test reagents/kits | Class C | A Estrogen / Progesterone test reagent/kit is a medical device intended for the detection of Estrogen / Progesterone in serum/body fluids. | |
| 27 | HER2 (Human Epidermal Growth Factor receptor, test reagents/kits | Class C | A HER2 (Human Epidermal Growth Factor receptor test reagent/kit is a medical device intended for the detection of HER2 (Human Epidermal Growth Factor receptor in serum/body fluids | |
| 28 | human Chorionic Goadotropin (hCG) test system test reagents/kits | Class C | A human Chorionic Goadotropin (hCG) test reagent/kit is a medical device intended for the detection of human Chorionic Goadotropin (hCG) in serum/body fluids | |
| 29 | Lipid associated sialic acid test reagents/kits | Class C | A Lipid associated sialic acid test reagent/kit is a medical device intended for the detection of Lipid associated sialic acid in serum/body fluids. | |
| 30 | Neuron -Specific Enolase (NSE) test reagents/kits | Class C | A Neuron -Specific Enolase (NSE) test reagent/kit is a medical device intended for the detection of Neuron-Specific Enolase (NSE) in serum/body fluids | |
| 31 | NMP22 test reagents/kits | Class C | A NMP22 test reagent/kit is a medical device intended for the detection of NMP22 in serum/body fluids. | |
| 32 | Prostate-Specific Antigen (PSA) test reagents/kits | Class C | A Prostate-Specific Antigen (PSA) test reagent/kit is a medical device intended for the detection of Prostate-Specific Antigen (PSA) in serum/body fluids. | |
| 33 | Prostatic Acid Phosphatase (PAP) test reagents/kits | Class C | A Prostatic Acid Phosphatase (PAP) test reagents/kits test reagent/kit is a medical device intended for the detection of Prostatic Acid Phosphatase (PAP) test reagents/kits in serum/body fluids | |
| 34 | Prostate Cancer Antigen 3 gene (PCA 3) test reagents /kits | Class C | A Prostate Cancer Antigen 3 gene (PCA 3) test reagent/kit is a medical device intended for the detection of Prostate Cancer Antigen 3 gene (PCA 3) in serum/body fluids | |
| 35 | Prostate-Specific Membrane Antigen (PSMA) test reagent /kits | Class C | A Prostate-Specific Membrane Antigen (PSMA) test reagent/kit is a medical device intended for the detection of Prostate-Specific Membrane Antigen (PSMA) in serum/body fluids | |
| 36 | S-100 test reagents/kits | Class C | A S-100 test reagent/kit is a medical device intended for the detection of S-100 in serum/body fluids | |
| 37 | TA-90 test reagents/kits | Class C | A TA-90 test reagent/kit is a medical device intended for the detection of TA-90 in serum/body fluids | |
| 38 | Thyroglobulin test reagents /kits | Class C | A Thyroglobulin test reagent/kit is a medical device intended for the detection of Thyroglobulin in serum/body fluids | |
| 39 | Tissue Polypeptide Antigen (TPA) test reagents/kits | Class C | A Tissue Polypeptide Antigen (TPA) test reagent/kit is a medical device intended for the detection of Tissue Polypeptide Antigen (TPA) in serum/body fluids | |
| 40 | Other Reagents/ Kits for detection of Cancer Markers | Class C | ||
| 41 | Reagents/ Kits for estimation of Coagulation parameters exemplified as:
|
PT (Prothrombin Time) test reagents/kits | Class C | A Prothrombin Time (PT)test reagent/kit is a medical device intended for the estimation of prothrombin time in plasma/body fluids. |
| 42 | TT (Thrombin Time) test reagents/kits | Class C | A Thrombin Time(TT)test reagent/kit is a medical device intended for the estimation of Thrombin Time in plasma /body fluids. | |
| 43 | Activated Partial Thromboplastin Time(APTT) testsreagents/kits |
Class C | A Activated Partial ThromboplastinTime (APTT) test reagent/kit is a medical device intended for the estimation of Activated Partial ThromboplastinTime in plasma/body fluids | |
| 44 | Activated whole blood clotting time tests reagents /kits | Class C | A Activated whole blood clotting time test reagent/kit is a medical device intended for the estimation of Activated whole blood clotting Time in plasma/body fluids. | |
| 45 | Fibrinogen/Fibrin degradation products tests reagents/kits | Class C | A Fibrinogen/Fibrin degradation products test reagent/kit is a medical device intended for the estimation of fibrinogen /fibrin degradation products in plasma/body fluids | |
| 46 | D-Dimer tests reagents/kits | Class C | A D-Dimer test reagent/kit is a medical device intended for the estimation of D-Dimer test in plasma/body fluids | |
| 47 | Other Reagents/ Kits for estimation of Coagulation parameters | Class C | ||
| 48 | Reagents/ Kits for monitoring of drug levels used for therapy or abuse exemplified as under
|
Aminoglycoside antibiot ics test reagents/kits | Class C | Aminoglycoside antibiotics test reagents/kits are medical devices intended for the estimation of Aminoglycoside antibiotics in serum/body fluids. |
| 49 | Antiepileptics test reagents /kits | Class C | Antiepileptics test reagents/kits are medical devices intended for the estimation of Antiepileptics in serum/body fluids. | |
| 50 | Antipsychotics test reagents /kits | Class C | Antipsychotics test reagents/kits are medical devices intended for the estimation of Antipsychotics in serum/body fluids. | |
| 51 | Mood stabilisers, test reagents /kits | Class C | Mood stabilisers test reagents/kits are medical devices intended for the estimation of Mood stabilisers in serum /body fluids | |
| 52 | Biologic monoclonal antibody drugs test reagents /kits | Class C | Biologic monoclonal antibody drugs test reagents/kits are medical devices intended for the estimation of Biologic monoclonal antibody drugs in serum/body fluids. | |
| 53 | Buprenorphine (BUP) test reagents/kits | Class C | Buprenorphine (BUP) test reagents/kits are medical devices intended for the estimation of Buprenorphine (BUP) in serum/body fluids | |
| 54 | Amphetamine (AMP)test reagents/kits | Class C | Amphetamine (AMP) test reagents/kits are medical devices intended for the estimation of Amphetamine (AMP) in serum/body fluids. | |
| 55 | Barbiturates ( BAR) test reagents/kits | Class C | Barbiturates ( BAR) test reagents/kits are medical devices intended for the estimation of Barbiturates ( BAR) in serum/body fluids | |
| 56 | Opiate test system test reagents /kits | Class C | Opiate test reagents/kits are medical devices intended for the estimation of opiates in serum/body fluids | |
| 57 | Benzodiazepines (BZO)Test reagents /kits | Class C | Benzodiazepines (BZO) test reagents/kits are medical devices intended for the estimation of Benzodiazepines (BZO) in serum/body fluids | |
| 58 | Cocaine (COC) Test reagents /kits | Class C | Cocaine (COC) test reagents/kits are medical devices intended for the estimation of Cocaine (COC)in serum/body fluids. | |
| 59 | Cotinine (COT) Test reagents /kits | Class C | Cotinine (COT) test reagents/kits are medical devices intended for the estimation of Cotinine (COT) in serum/body fluids. | |
| 60 | Ketamine ( KET )Test reagents /kits | Class C | Ketamine (KET) test reagents/kits are medical devices intended for the estimation of Ketamine ( KET )in serum/body fluids. | |
| 61 | Ecstasy ( MDMA ) Test reagents /kits | Class C | Ecstasy ( MDMA ) test reagents/kits are medical devices intended for the estimation of Ecstasy ( MDMA )in serum /body fluids | |
| 62 | Methamphetamine (MET ) Test reagents /kits | Class C | Methamphetamine ( MET ) test reagents/kits are medical devices intended for the estimation of Methamphetamine (MET) in serum/body fluids | |
| 63 | Morphine ( MOP )Test reagents /kits | Class C | Morphine (MOP) test reagents/kits are medical devices intended for the estimation of Morphine (MOP) in serum /body fluids. | |
| 64 | Methaqualone (MQL)Test reagents /kits | Class C | Methaqualone (MQL) test reagents/kits are medical devices intended for the estimation of Methaqualone (MQL)in serum/body fluids. | |
| 65 | Methadone ( MTD) Test reagents /kits | Class C | Methadone (MTD)test reagents/kits are medical devices intended for the estimation of Methadone ( MTD )in serum /body fluids. | |
| 66 | Oxycodone (OXY)Test reagents /kits | Class C | Oxycodone (OXY) test reagents/kits are medical devices intended for the estimation of Oxycodone (OXY) in serum /body fluids. | |
| 67 | Phencyclidine ( PCP ) Test reagents /kits | Class C | Phencyclidine (PCP) test reagents/kits are medical devices intended for the estimation of Phencyclidine (PCP) in serum /body fluids | |
| 68 | Propoxyphene ( PPX ) Test reagents /kits | Class C | Propoxyphene (PPX) test reagents/kits are medical devices intended for the estimation of Propoxyphene (PPX) in serum/body fluids | |
| 69 | Tricyclic Antidepressants (TCA)Test reagents /kits |
Class C | Tricyclic Antidepressants (TCA) test reagents/kits are medical devices intended for the estimation of Tricyclic Antidepressants (TCA) in serum/body fluids | |
| 70 | Marijuana (THC)Test reagents /kits | Class C | Marijuana (THC) test reagents/kits are medical devices intended for the estimation of Marijuana (THC) in serum/body fluids | |
| 71 | Tramadol (TRA ) Test reagents /kits | Class C | Tramadol (TRA) test reagents/kits are medical devices intended for the estimation of Tramadol (TRA) in serum/body fluids | |
| 72 | Fentanyl (FEN)Test reagents /kits | Class C | Fentanyl (FEN) test reagents/kits are medical devices intended for the estimation of Fentanyl (FEN) in serum/body fluids | |
| 73 | Methadone Metabolite (EDDP)Test reagents /kits. | Class C | Methadone Metabolite (EDDP) test reagents/kits are medical devices intended for the estimation of Methadone Metabolite ( EDDP )in serum/body fluids | |
| 74 | Other Reagents/ Kits for monitoring of drug levels used for therapy or abuse |
Class C | ||
| 75 | Reagents/ Kits for detection of markers for Congenital disorders exemplified as under
|
Triple Screen Test reagents /kits for Down’s Syndrome | Class C | Triple Screen Test reagent/kit for Down’s Syndrome is a medical device intended for the screening of Down’s Syndrome in serum/plasma. |
| 76 | Quadruple Screen Test reagents /kits for Down’s Syndrome | Class C | Quadruple Screen Test reagent/kit for Down’s Syndrome is a medical device intended for the screening of Down’s Syndrome in serum/plasma | |
| 77 | Chorionic Villus Sample Test reagents/kits for Down’s Syndrome | Class C | Chorionic Villus Sample Test reagent/kit for Down’s Syndrome is a medical device intended for the detection of Down’s Syndrome in body fluids. | |
| 78 | Maternal Serum Alpha- Fetoprotein (MSAFP) test reagents/kits for spina bifida |
Class C | Maternal Serum Alpha-Fetoprotein (MSAFP) Test reagents/kits for is a medical device intended for the screening of spina bifida in serum. | |
| 79 | Others Reagents/ Kits for detection of Congenital disorders | Class C | ||
| 80 | Reagents/ Kits for detection of Cardiac Markers exemplified as under | Troponin test reagents/kits | Class C | A Troponin test reagent/kit for near patient testing, is a medical device intended for the estimation of Troponin T,I and its variants in blood /body fluids. |
| 81 | BNP &NT pro BNP test reagents /kits. | Class C | BNP &NT pro BNP Test reagent/kit for is a medical device intended for theestimation of BNP &NT pro BNP in blood / body fluids. | |
| 82 | Reagents/ Kits for human Genetic testing exemplified as: |
Genetic test reagents/kits for Cystic Fibrosis. | Class C | Genetic test reagent/kit for Cystic Fibrosis is a medical device intended for the detection of Cystic Fibrosis in human specimens. |
| 83 | Genetic test for Huntington’s chorea | Class C | Genetic test reagent/kit for Huntington’s chorea is a medical device intended for the detection of Huntington’s chorea in human specimens. | |
| 84 | Other Reagents/ Kits for human Genetic testing | Class C | ||
| 85 | Reagents/ Kits for the management of life threatening infections exemplified as under:
|
HIV Viral Load test reagents /kits. | Class C | HIV Viral Load test reagent/kit is a medical device intended for the estimation of HIV Viral Load in blood/body fluids. |
| 86 | HBV Viral Load test reagents /kits. | Class C | HBV Viral Load test reagent/kit is a medical device intended for the estimation of HBV Viral Load in blood/body fluids. | |
| 87 | HCV Viral Load test reagents /kits. | Class C | HCV Viral Load test reagent/kit is a medical device intended for the estimation of HCV Viral Load in blood/body fluids. | |
| 88 | CD4 Count & % test reagents /kits | Class C | CD4 Count & % test reagent/kit is a medical device intended for the estimation of CD4 Count & % in blood/body fluids. | |
| 89 | CD8 Count & % test reagents /kits | Class C | CD8 Count & % test reagent/kit is a medical device intended for the estimation of CD8 Count & % in blood/body fluids. | |
| 90 | CD4/CD8 Ratio test reagents /kits | Class C | CD4/CD8 Ratio test reagent/kit are a medical device intended for the estimation of CD4/CD8 Ratio in blood/body fluids. | |
| 91 | Other Reagents/ Kits for the management of life threatening infections | Class C | ||
| 92 | Reagents/ Kits for the detection of sexually transmitted agent exemplified as under:
|
Treponema pallidum test reagents and kits. | Class C | Treponema pallidum test reagent/kit is a medical device intended for the detection of Treponema pallidum in blood /body fluids. Ids |
| 93 | Neisseria gonorrhoeae test reagents and kits | Class C | Neisseria gonorrhoeae test reagent/kit is a medical device intended for the detection of Neisseria gonorrhoeae in blood/body fluids. | |
| 94 | Human Papilloma Virus (HPV) test reagents and kits | Class C | Human Papilloma Virus (HPV) test reagent/kit is a medical device intended for the detection of Human Papilloma Virus in blood/body fluids. | |
| 95 | Chlamydia test reagents and kits | Class C | Chlamydia test reagent/kit is a medical device intended for the detection of Chlamydia in blood/body fluids. | |
| 96 | Herpes Virus test reagents and kits | Class C | Herpes Virus test reagent/kit is a medical device intended for the detection of Herpes Virus in blood/body fluids. | |
| 97 | Other Reagents/ Kits for the detection of sexually transmitted agent | Class C | ||
| 98 | Reagents/ Kits for the Antigen detection of infectious agents with a risk of limited propagation exemplified as:
|
Malaria Antigen test reagents and kits | Class C | Malaria Antigen test reagent/kit is a medical device intended for the detection of Malaria Antigen in blood/body fluids. |
| 99 | Dengue virus Antigen test reagents and kits | Class C | Dengue virus Antigen test reagent/kit is a medical device intended for the detection of Dengue virus Antigen in blood/body fluids. | |
| 100 | Chikungunya Antigen test reagents and kits. | Class C | Chikungunya Antigen test reagent/kit is a medical device intended for the detection Chikungunya Antigen of in blood/body fluids | |
| 101 | Leptospira Antigen test reagents and kits | Class C | Leptospira Antigen test reagent/kit is a medical device intended for the detection of Leptospira Antigen in blood /body fluids. | |
| 102 | Japanese Encephalitis Antigen test reagents and kits | Class C | Japanese Encephalitis Antigen test reagent/kit is a medical device intended for the detection of Japanese Encephalitis Antigen in blood/body fluids. | |
| 103 | Typhoid Antigens test reagents and kits | Class C | Typhoid Antigens Test reagent/kit is a medical device intended for the detection of Typhoid Antigens in blood/body fluids. | |
| 104 | Influenza A Antigen test reagents and kits | Class C | Influenza A Antigen test reagent/kit is a medical device intended for the detection of Influenza A Antigen in blood /body fluids. | |
| 105 | Influenza B Antigen test reagents and kits | Class C | Influenza B Antigen test reagent/kit is a medical device intended for the detection of Influenza B Antigen in blood /body fluids. | |
| 106 | Strep A Antigen test reagents and kits | Class C | Strep A Antigen test reagent/kit is a medical device intended for the detection of Strep A Antigen in blood /body fluids. | |
| 107 | Strep B Antigen test reagents and kits | Class C | Strep B test Antigen reagent/kit is a medical device intended for the detection of Strep B Antigen in blood /body fluids | |
| 108 | Chagas Antigen test reagents and kits | Class C | Chagas disease Antigen test reagent/kit is a medical device intended for the detection of Chagas disease Antigen in blood/body fluids | |
| 109 | Filariasis Antigen test reagents and kits | Class C | Filariasis test Antigen reagent/kit is a medical device intended for the detection of Filariasis Antigen in blood/body fluids | |
| 110 | Kala Azar Antigen test reagents and kits gen | Class C | Kala Azar Antigen test reagent/kit is a medical device intended for the detection of Kala Azar Antigen in blood/body fluids | |
| 111 | Rotavirus Antigen test reagents and kits | Class C | Rotavirus Antigen test reagent/kit is a medical device intended for the detection of Rotavirus Antigen in blood/body fluids. | |
| 112 | S. pneumonia Antigen test reagents and kits. | Class C | S. pneumonia Antigen test reagent/kit is a medical device intended for the detection of S. pneumonia Antigen in blood/body fluids. | |
| 113 | H. pylori Antigen Antigen test reagents and kits Antigen | Class C | H. pylori Antigen test reagent/kit is a medical device intended for the detection of H. pylori Antigen in blood/body fluids | |
| 114 | Other Reagents/ Kits for the detection of infectious agents with a risk of limited propagation | Class C | Reagents/ Kits, other than above, for the Antigen detection of infectious agents with a risk of limited propagation. | |
| 115 | In vitro Diagnostic Medical Devices for Blood Grouping or Tissue Typing |
All other than, the ABO system; the Duffy system the Kell system; the Kidd system; the Rhesus system, test reagents/kits. | Class C |
(iii) Class D In Vitro Diagnostics Medical Devices:
| S. No. | Category | In vitro diagnostic medical device |
Risk Class | Intended use |
| 1 | In vitro Diagnostic Medical Devices for Blood Grouping or Tissue Typing
|
ABO System test reagents /kits | Class D | Intended for blood grouping or tissue typing. |
| 2 | Rhesus (D) System test reagents /kits | Class D | ||
| 3 | The Duffy system test reagents /kits | Class D | ||
| 4 | The Kell system test reagents /kits | Class D | ||
| 5 | The Kidd system test reagents /kits | Class D | ||
| 6 | HLA test reagents/kits | Class D | ||
| 7 | Reagents/ Kits for the detection of transmissible agents -screening & confirmatory
|
HIV test reagents/kits | Class D | HIV test reagents/kits is a medical device intended for the detection of HIV in blood/body fluids. |
| 8 | HBV test reagents/kits | Class D | HBV test reagents/kits is a medical device intended for the detection of HBV in blood/body fluids | |
| 9 | HCV test reagents/kits | Class D | HCV test reagents/kits is a medical device intended for the detection of HCV in blood/body fluids | |
| 10 | Syphilis screening reagents /kits | Class D | Syphilis test reagents/kits is a medical device intended for the screening of Syphilis in blood/body fluids | |
| 11 | Malaria screening reagents /kits | Class D | Malaria test reagents/kits is a medical device intended for the screening of Malaria in blood/body fluids |
| S. No. | Category | In vitro diagnostic medical device |
Risk Class | Intended use |
| 1 | Ferritin test reagents/kits | An Ferritin test reagent/kit is a medical device intended for the estimation of ferritin in serum /plasma | ||
| 2 | Other test reagents/kits for vitamins | Test reagents/kits for the estimation of other than above vitamins in blood/body fluids | ||
| 3 | Homocystein test reagents /kits | Homocystein test reagent/kit is a medical device intended for the estimation of Homocystein in blood/body fluids | ||
| 4 | allergens test reagents/kits | Test reagents/kits intended for the estimation of allergens in blood/body fluids | ||
| 5 | calibrators/controls for above all in vitro diagnostic medical devices |
Calibrators | Calibrators intended to be used with a reagent should be treated in the same class as the In vitro diagnostic medical device reagent. | |
| 6 | Controls | Controls intended to be used with a reagent should be treated in the same class as the In vitro diagnostic medical device reagent |
