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 AuthorityEnforcement 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 AuthorityEnforcement 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-A101000
Class-B101000
Class-C5003000
Class-D5003000

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.CategoryIn vitro diagnostic
medical device
Risk ClassIntended use
1Clinical Chemistry Reagents/Kits for estimation of various Parameters exemplified as:   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Acid Phosphatase (total or prostatic) test reagents/kitsClass BAn acid phosphatase (total or prostatic) test reagent/kit is a medical device, intended for the estimation of acid phosphatase in serum/plasma.
2Albumin test reagents/kitsClass BAn albumin test reagent/kit is a medical device intended for the estimation of albumin in serum/plasma.
3Alkaline phosphatase or isoenzymes test reagents/kitsClass BAn alkaline phosphatase or isoenzymes test reagent/kit is a medical device intended for the estimation of alkaline phosphatase or its isoenzymes in serum/plasma.
4Ammonia test reagents/kitsClass BAn ammonia test reagent/kit is a medical device intended for the estimation of ammonia levels in blood, serum /plasma.
5Amylase test reagents/kitsClass BAn amylase test reagent/kit is a medical device intended for the estimation of the enzyme amylase in serum, saliva / urine.
6Bicarbonate / carbon dioxide test reagents/kitsClass BA bicarbonate/carbon dioxide test reagent/kit s a medical device for the estimation of bicarbonate /carbon dioxide in plasma, serum/whole blood.
7bilirubin (total and direct) test reagents/kitsClass BA bilirubin (total and direct) test reagent/kit is a medical device intended for the estimation of bilirubin (total and direct) in serum/plasma.
8Calcium  test reagents/kitsClass BA calcium test reagent/kit is a medical device intended for the estimation of total calcium in serum.
9Chloride test reagents/kitsClass BA chloride test reagent/kit is a medical device intended for the estimation of chloride in plasma, serum, sweat /urine.
10cholesterol (total) test reagents/kitsClass BA cholesterol (total) test reagent/kit is a medical device intended for the estimation of cholesterol in serum or plasma.
11HDL cholesterol test reagents /kitsClass BA HDL cholesterol test reagent/kit is a medical device intended for the estimation of HDL cholesterol in serum / plasma.
12LDL cholesterol test reagents /kitsClass BA LDL cholesterol test reagent/kit is a medical device intended for the estimation of LDL cholesterol in serum/plasma.
13Lipoproteinstest reagents /kitsClass BA lipoprotein test reagent/kit is a medical device intended for the estimation of lipoproteins in serum / plasma.
14Cholinesterase  test reagents /kitsClass BA cholinesterase test reagent/kit is a medical device intended for the estimation of cholinesteral in serum/plasma.
15Creatine Kinase and its
isoenzymestest reagents/kits
Class BA 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.
16Copper test reagents/kitsClass BCopper test reagent/kit is a medical device intended for the estimation of copper in plasma, serum / urine.
17Creatinine test reagents/kitsClass BA creatinine test reagent/kit is a medical device intended for the estimation of creatinine in serum, plasma / urine.
18Gamma  Glutamyl Transferase (GGT)  and isoenymes test reagents /kitsClass BA 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.
19Glucose test reagents/kitsClass BA Glucose test reagent/kit is a medical device intended for the estimation of glucose in blood/plasma/ body fluids.
20Glucose-6-Phosphate
Dehydrogenase (G6PD) and its isoenzymes test reagents/kits.
Class BA 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.
21Glycosylated Hemoglobin or its variants test reagents/kitsClass BGlycosylated 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.
22Hemoglobin  test reagents /kitsClass BA hemoglobin test reagent/kit is a medical device intended for the estimation of hemoglobin in blood.
23Iron test reagents/kitsClass BAn iron test reagent/kit is a medical device intended for the estimation of iron in serum /plasma.
25Iron-binding capacity
test reagents /kits
Class BIron-binding capacity test reagents/kits are medical devices intended for the estimation of iron-binding capacity in serum / plasma.
26Lactate Dehydrogenase and its isoenzymes test reagents /kitsClass BA 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.
27Lipase test reagents/kitsClass BA lipase test reagent/kit is a medical device intended for the estimation of lipase in serum / plasma.
28Magnesium test reagents /kitsClass BA magnesium test reagent/kit is a medical device intended for the estimation of magnesium levels in serum / plasma
29Phosphorus (inorganic) test reagents /kitsClass BA phosphorus (inorganic) test reagent/kit is a medical device intended for the estimation of inorganic phosphorus in serum, plasma / urine.
30Potassium  test reagents/kitsClass BA potassium test reagent/kit is a medical device intended for the estimation of potassium in serum, plasma / urine.
31Aspartate Amino Transferase
(AST/SGOT) test reagents /kits
Class BAn 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.
32Alanine Amino Transferase
(ALT/SGPT) test reagents /kits
Class BAn 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.
33Sodium  test reagents/kitsClass BA Sodium test reagent/kit is a medical device intended for the estimation of sodium in serum/ plasma / urine.
34Total protein test reagents /kitsClass BA Total Protein test reagent/kit is a medical device intended for the estimation of total protein(s) in serum / plasma.
35Protein (fractionation) test reagents /kitsClass BA Protein (fractionation) test reagent/kit is a medical device intended for the estimation of protein
fractions in blood, urine, cerebrospinal fluid / other body fluids.
36Protein-bound iodine test reagents /kitsClass BA Protein-bound iodine test reagent/kit is a medical device intended for the estimation of protein-bound iodine in serum /plasma.
37Triglycerides test reagents /kitsClass BA Triglyceride test reagent/kit is a medical device intended for the estimation of triglycerides in serum /plasma.
38Urea (BUN) test reagents /kitsClass BA Urea (BUN) test reagent/kit is a medical device intended for the estimation of urea/Blood Urea Nitrogen (BUN) in plasma/ serum /urine.
39Uric Acid test reagents/kitsClass BA Uric Acid test reagent/kit is a medical device intended for the estimation of uric acid in serum/plasma / urine.
40Micro-Protein test reagents /kitsClass BA Micro-protein test reagent/kit is a medical device intended for the estimation of micro-proteins including micro-albumin in urine.
41Zinc test reagents/kitsClass BA Zinc test reagent/kit is a medical device intended for the estimation of zinc in serum / plasma.
42Other clinical chemistry test reagents/kitsClass BClinical chemistry test reagent/kit intended for the estimation of analytes/ parameters (other than listedabove) in serum/ plasma/ urine or other body fluids.
43Hematology Reagents/Kits for estimation of Complete Blood Counts , exemplified as:  Blood cell DiluentsClass BA blood cell Diluent is a medical device used to dilute blood for further testing, such as Complete Blood Count(CBC).
44Lyse  reagents/kits for differential countsClass BA Lyse reagent/kit is a medical device used for lysing of cells for the estimation of Complete Blood Count(CBC).
45Rinse/Detergent/Cleaners reagents/kitsClass BA Rinse/Detergent/Cleaner reagent/kit is a medical device used for cleaning various parts of Hematology analyzers like probes, needles, baths, tubing etc.
46Reagents/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/kitsClass BAscorbic 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
47In – vitro 47. Diagnostic Medical Devices for Self -Testing   

 

 

 

Glucose test reagents/kitsClass BA glucose test reagent/kit is a medical device intended for the preliminary self testing of glucose levels in blood /body fluids.
48Human Chorionic Gonadotropin (hCG) test reagents/kitsClass BA human Chorionic Gonadotropin (hCG) test reagent/kit is a medical device intended for the preliminary self testing of hCG in urine/body fluids.
49Luteinizing Hormone (LH) test reagents/kitsClass BA Luteinizing Hormone (LH) test reagent/kit is a medical device intended for the preliminary self  testing of Luteinizing Hormone (LH) in urine/body fluids.
50Glycosylated hemoglobinor its variants  Test reagents /kitsClass BGlycosylated 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.
51Cholesterol test reagents /kitsClass BA Cholesterol test reagent/kit is a medical device intended for preliminary self testing of cholesterol in blood /body fluids.
52Follicle Stimulating Hormone (FSH) test reagents /kitsClass BA 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
53Other  In – vitro Diagnostic Medical Devices for Self –
Testing
Class B
54Reagents/ Kits for detection of autoimmune disorders exemplified as:   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Anti Nuclear Antibodies test reagents/kitsClass BAnti Nuclear Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to nuclear antigens in human specimens.
55Anti Transglutaminase Antibodies test reagents /kitsClass BAnti Transglutaminase Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to Transglutaminase in human specimens.
56Anti Ganglioside Antibodies test reagents/kitsClass BAnti Ganglioside Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to Ganglioside in human specimens.
57Anti-Cyclic Citrullinated Peptide (CCP) Antibodies test reagents/kitsClass BAnti CyclicCitrullinated Peptide (CCP) Antibodies test reagent/kit is a medical device for the screening of CCP auto-antibodies in human specimens.
58Rheumatoid Factor (RF) immunological test reagents /kitsClass BRheumatoid Factor (RF) immunological test reagent/kit is a medical device for the screening of Rheumatoid Factor in human specimens.
59Anti Smooth Muscle Antibody test reagents/kitsClass BAnti Smooth Muscle Antibody test reagent/kit is a medical device for the screening of auto-antibodies to smooth muscles in human specimens.
60Glutamic Acid Decarboxylase (GAD) Antibody test reagents /kitsClass BGlutamic Acid Decarboxylase (GAD) Antibodytest reagent/kit is a medical device for the screening of auto- antibodies to Glutamic Acid Decarboxylase (in human specimens.
61Anti ovary antibodies test reagents/kitsClass BAnti ovary antibodies test reagent/kit is a medical device for the screening of auto-antibodies to ovarian antigens in human specimens
62Anti sperm Antibodies test
reagents/kits
Class BAnti sperm antibodies test reagent/kit is a medical device for the screening of auto-antibodies to spermatozoa in human specimens.
63Anti-IA2 test reagents/kitsClass BAnti IA-2 antibodies test reagent/kit is a medical device for the screening of auto-antibodies to IA-2 (tyrosine phosphatase) in human specimens.
64Anti-Acetylcholine Receptor test reagents/kits.Class BAnti-Acetylcholine Receptor test reagent/kit is a medical device for the screening of auto-antibodies to Acetylcholine Receptor in human specimens.
65Anti Thyroid gland antibody test reagents/kits.Class BAnti Thyroid gland antibodies test reagent/kit is a medical device for the screening of auto-antibodies to thyroid gland antigens in human specimens.
66ANCA test reagents/kitsClass BThe ANCA test reagent/kit is a medical device for the screening of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) in human specimens.
64Anti-double stranded DNA (anti-dsDNA) test reagents /kitsClass BThe 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.
65Anti-Extractable Nuclear Antigen(Anti- ENA)test reagents /kits.Class BThe 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.
66Anti-Intrinsic Factor test reagents /kitsClass BThe Anti-Intrinsic Factor test reagent/kit is a medical device for the screening of antibodies against intrinsic factor in human specimens.
67Anti-Saccharomyces Cerevisiae Antibodies (ASCA) test reagents/kitsClass BThe Anti-Saccharomyces Cerevisiae Antibodies (ASCA) test reagent/kit is a medical device for the screening of antibodies against Saccharomyces Cerevisiae in human specimens.
68Other Reagents/ Kits for detection of autoimmune disordersClass B
69Reagents/ Kits for detection of Cardiac Markers exemplified as underCreatine Kinase (CK) and CKMB test reagents/kitsClass BCreatine Kinase (CK) and CKMB test reagent/kit are medical devices intended for the estimation of Creatine Kinase (CK) and CKMB in blood / body fluids.
70Myoglobin test reagents /kitsClass BMyglobin Test reagent/kit for is a medical device intended for the estimation of myglobin in blood /body fluids.
71Reagents/ Kits for the detection of Antibodies to infectious agents with a risk of limited propagation exemplified as under:   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Malaria Antibody test reagents and kitsClass BMalaria Antibody test reagent/kit is a medical device intended for the detection of Malaria Antibody in blood/body fluids
72Dengue Antibody test reagents and kitsClass BDengue Antibody test reagent/kit is a medical device intended for the detection of Dengue Antibody in blood/body fluids.
73Chikungunya Antibody test reagents and kitsClass BChikungunya Antibody test reagent/kit is a medical device  intended for the detection of Chikungunya Antibody in blood/body fluids.
74Leptospira Antibody test reagents and kitsClass BLeptospira Antibody test reagent/kit is a medical device intended for the detection of Leptospira Antibody in blood /body fluids
75Japanese Encephalitis Antibody test reagents and kitsClass BJapanese Encephalitis Antibody test reagent/kit is a medical device intended for the detection of Japanese Encephalitis Antibody in blood/body fluids.
76Typhoid Antibody test reagents and kitsClass BTyphoid Antibody test reagent/kit is a medical device intended for the detection of Typhoid Antibody in blood/body fluids
77Cryptococcus  neoformans Antibody test reagents and kitsClass BCryptococcus neoformans Antibody test reagent/kit is a medical device intended for the detection Cryptococcus neoformans Antibody in blood/body fluids.
78Neisseria meningitides Antibody test reagents and kits.Class BNeisseria meningitides Antibody test reagent/kit is a medical device intended for the detection of Neisseria meningitides Antibody in blood/body fluids
79Vibrio cholera Antibody test reagents and kitsClass BVibrio cholera Antibody test reagent/kit is a medical device  intended for the detection of Vibrio cholera Antibody in blood/body fluids
80Influenza A Antibody test reagents and kitsClass BInfluenza A Antibody test reagent/kit is a medical device intended for the detection of Influenza A Antibody in
blood/body fluids
81Influenza B Antibody test reagents and kitsClass BInfluenza B Antibody test reagent/kit is a medical device intended for the detection of Influenza B Antibody in blood /body fluids.
82Strep A Antibody test reagents and kitsClass BStrep A Antibody test reagent/kit is a medical device intended for the detection of Strep A Antibody in blood/body fluids
83Strep B Antibody test reagents and kitsClass BStrep B Antibody test reagents/kits is a medical device intended for the detection of Strep B Antibody in blood/body fluids
84Chagas Antibody test reagents and kitsClass BChagas Antibody test reagent/kit is a medical device intended for the detection of Chagas Antibody in blood/body fluids
85Filariasis Antibody test reagents and kitsClass BFilariasis Antibody test reagent/kit is a medical device intended for the detection of Filariasis Antibody in blood/body fluids.
86Kala Azar Antibody test reagents and kitsClass BKala Azar Antibody test reagents/kits is a medical device intended for the detection of Kala Azar Antibody in blood /body fluids
87Rotavirus Antibody test reagents and kitsClass BRotavirus Antibody test reagents/kits is a medical device intended for thedetection of Rotavirus Antibody in blood /body fluids
88S. pneumonia Antibody test reagents and kits.Class BS. pneumonia Antibody test reagent/kit is a medical device intended for the detection of S. pneumonia Antibody in blood/body fluids.
89H. pylori Antibody test reagents and kitsClass BH.pylori Antibody test reagent/kit is a medical device intended for the detection of H.pylori Antibody in blood/body fluids
90Other Reagents/ Kits for the detection of Antibodies to infectious agents with a risk of limited propagationClass B
91Other in vitro Medical Devices   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TSH test reagents/kitsClass BTSH test reagent/kit is a medical device intended for the estimation TSH in blood/body fluids.
92Total /Free triiodothyronine (T3) test reagents/kitsClass BTotal /Free triiodothyronine (T3) test reagent/kit is a medical device intended for the estimation Total /Free triiodothyronine (T3) in blood/body fluids
93Total / Free thyroxine (T4) test reagents/kitsClass BTotal / Free thyroxine (T4)test reagent/kit is a medical device intended for the estimation of Total / Free thyroxine (T4)in blood/body fluids.
94Dehydroepiandrosterone (DHEA-S) (free and sulfate) test reagents/kitsClass BDehydroepiandrosterone (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
95Estrogen test reagents/kitsClass BEstrogen test reagent/kit is a medical device intended for the estimation of Estrogen in blood/body fluids
96Progesterone test reagents /kitsClass BProgesterone test reagent/kit is a  medical device intended for the estimation of Progesterone in blood/body fluids
97Testosterone (Free and Total) test reagents/kitsClass BTestosterone (Free and Total) test reagent/kit is a medical device intended for the estimation of Testosterone (Free and Total) in blood/body fluids.
98Sex Hormone Binding Globulin (SHBG) test reagents /kitsClass BSex 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
99Cortisol test reagents/kitsClass BCortisol test reagent/kit is a medical device intended for the estimation of Cortisol in blood/body fluids
100Insulin test reagents/kitsClass BInsulin test reagent/kit is a medical device intended for the estimation of Insulin in blood/body fluids
101Luteinizing Hormone(LH) test reagents/kitsClass BLuteinizing Hormones (LH )test reagent/kit is a medical device  intended for the estimation of  Luteinizing Hormone (LH) in blood/body fluids.
102Follicle Stimulating Hormone (FSH) test reagents /kitsClass BFollicle Stimulating Hormone (FSH) test reagent/kit is a medical device intended for the estimation of Follicle Stimulating Hormone(FSH) in blood/body fluids.
103Prolactin test reagents/kitsClass BProlactin test reagent/kit is a medical device intended for the estimation of Prolactin in blood/body fluids
104Other test reagents/kits for hormonesClass BTest reagents/kits for the estimation of other than above hormones in blood/body fluids
105Vitamin B test reagents /kitsClass BVitamin B test reagent/kit is a medical device intended for the estimation of Vitamin B in blood/body fluids
106Vitamin D test reagents /kitsClass BVitamin D test reagent/kit is a  medical device intended for the estimation of Vitamin B in blood/body fluids
107Vitamin A test reagents/kitsClass BVitamin A test reagent/kit is a medical device intended for the estimation of Vitamin A in blood/body fluids
108Vitamin E test reagents /kitsClass BVitamin E test reagent/kit is a medical device intended for the estimation of Vitamin E in blood/body fluids
109Vitamin K test reagents /kitsClass BVitamin 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.CategoryIn vitro diagnostic
medical device
Risk ClassIntended use
1In – vitro Diagnostic Medical Device for near patient testing.   

 

 

 

Blood Gas Analysis test reagents /kitsClass CA 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.
2Anticoagulant monitoring test reagents/kitsClass CAn 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.
3Diabetes management test reagents/kitsClass CA Diabetes management test reagent/kit for near patient testing, is a medical device intended for the of monitoring of diabetes in body fluids.
4C- Reactive Protein (CRP)test reagents/kitsClass CA 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.
5H. pylori test reagents/kitsClass CAn H. pylori test reagent/kit for near patient testing, is a medical device intended for the estimation of H. pylori in blood/body fluids.
6Troponin test reagents/kitsClass CA 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
7Other in vitro Diagnostic Medical Devices for near patient test reagents/kitsClass CIn 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.
8Reagents/Kits for estimation of parameters
of ToRCH& other infectious agents exemplified as under:
   

 

 

 

Toxoplasma gondii test reagents /kitsClass CA Toxoplasma gondii test reagent/kit is a medical device intended for the detection of Toxoplasma gondii in serum /body fluids.
9Rubella virus l test reagents /kitsClass CA Rubella virus test reagent/kit is a medical device intended for the detection of Rubella virus in serum/body fluids.
10Cytomegalovirus test reagents /kitsClass CA Cytomegalovirus test reagent/kit is a medical device intended for the detection of Cytomegalovirus in serum/body fluids.
11Herpes simplex virus reagents /kitsClass CA Herpes simplex virus test reagent/kit is a medical device intended for the detection of Herpes simplex virus in serum /body fluids.
12Chlamydia pneumoniae test reagents/kitsClass CA Chlamydia pneumoniae test reagent/kit is a medical device  intended for the detection of Chlamydia pneumonia in serum/body fluids.
13Methicillin-Resistant Staphylococcus aureus test reagents/kitsClass CA Methicillin-Resistant Staphylococcus aureus test reagent/kit is a medical device intended for the detection of Methicillin-ResistantStaphylococcus aureus in serum/body fluids
14Enterovirus test reagents /kitsClass CAn Enterovirus test reagent/kit is a medical device intended for the detection of enterovirus) in serum/body fluids.
15Reagents/Kits for detection of Cancer Markers exemplified as :   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Alpha-fetoprotein test
reagents /kits
Class CAn Alpha-fetoprotein test reagent/kit is a medical device intended for the detection of Alpha-fetoprotein in serum /body fluids.
16Beta-2 microglobulin test reagents /kitsClass CA Beta-2 microglobulin test reagent/kit is a medical device intended for the detection of Beta-2 microglobulin in serum /body fluids
17Bladder tumour antigen (BTA) test reagents/kitsClass CA Bladder tumour antigen (BTA) test reagent/kit is a medical device intended for the detection of Bladder tumour antigen (BTA)in serum/body fluids
18CA15-3 test reagents /kitsClass CA CA15-3 antigen (BTA) test reagent/kit is a medical device intended for the detection of CA15-3 in serum/body fluids
19CA27.29 test reagents/kitsClass CA CA27.29 test reagent/kit is a medical device intended for the detection of CA27.29 in serum/body fluids
20CA125 test reagents/kitsClass CA CA125test reagent/kit is a medical device intended for the detection of CA125 in serum/body fluids
21CA72-4 test reagents/kitsClass CA CA72-4 test reagent/kit is a medical device intended for the detection of CA72-4 in serum/body fluids
22CA19-9 test reagents/kitsClass CA CA19-9 test reagent/kit is a medical device intended for the detection of CA19-9 in serum/body fluids
23Calcitonin test reagents /kitsClass CA Calcitonin test reagent/kit is a medical device intended for the  detection of Calcitonin in serum/body fluids
24Carcinoembryonic antigen (CEA) test reagents/kitsClass CA Carcinoembryonic antigen (CEA) test reagent/kit is a medical device intended for the detection of Carcinoembryonic antigen (CEA) in serum/body fluids
25Chromogranin A testreagents /kitsClass CA Chromogranin A test reagent/kit is a medical device intended for the detection of Chromogranin A in serum/body fluids
26Estrogen / Progesterone receptors test reagents/kitsClass CA Estrogen / Progesterone test reagent/kit is a medical device intended for the detection of Estrogen / Progesterone in serum/body fluids.
27HER2 (Human Epidermal Growth Factor receptor, test reagents/kitsClass CA 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
28human Chorionic Goadotropin (hCG) test system test reagents/kitsClass CA human Chorionic Goadotropin (hCG) test reagent/kit is a medical device intended for the detection of human Chorionic Goadotropin (hCG) in serum/body fluids
29Lipid associated sialic acid test reagents/kitsClass CA Lipid associated sialic acid test reagent/kit is a medical device intended for the detection of Lipid associated sialic acid in serum/body fluids.
30Neuron -Specific Enolase (NSE) test reagents/kitsClass CA Neuron -Specific Enolase (NSE) test reagent/kit is a medical device intended for the detection of Neuron-Specific Enolase (NSE) in serum/body fluids
31NMP22 test reagents/kitsClass CA NMP22 test reagent/kit is a medical device intended for the detection of NMP22 in serum/body fluids.
32Prostate-Specific Antigen (PSA) test reagents/kitsClass CA Prostate-Specific Antigen (PSA) test reagent/kit is a medical device intended for the detection of Prostate-Specific Antigen (PSA) in serum/body fluids.
33Prostatic Acid Phosphatase (PAP) test reagents/kitsClass CA 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
34Prostate Cancer Antigen 3 gene (PCA 3) test reagents /kitsClass CA 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
35Prostate-Specific Membrane Antigen (PSMA) test reagent /kitsClass CA 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/kitsClass CA 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/kitsClass CA TA-90 test reagent/kit is a medical device intended for the detection of TA-90 in serum/body fluids
38Thyroglobulin test reagents /kitsClass CA Thyroglobulin test reagent/kit is a medical device intended for the detection of Thyroglobulin in serum/body fluids
39Tissue Polypeptide Antigen (TPA) test reagents/kitsClass CA Tissue Polypeptide Antigen (TPA) test reagent/kit is a medical device intended for the detection of Tissue Polypeptide Antigen (TPA) in serum/body fluids
40Other Reagents/ Kits for detection of Cancer MarkersClass C
41Reagents/ Kits for estimation of Coagulation
parameters exemplified as:
   

 

 

 

PT (Prothrombin Time) test reagents/kitsClass CA Prothrombin Time (PT)test reagent/kit is a medical device  intended for the estimation of prothrombin time in plasma/body fluids.
42TT (Thrombin Time) test reagents/kitsClass CA Thrombin Time(TT)test reagent/kit is a medical device intended for the estimation of Thrombin Time in plasma /body fluids.
43Activated Partial Thromboplastin Time(APTT)
testsreagents/kits
Class CA Activated Partial ThromboplastinTime (APTT) test reagent/kit is a medical device  intended for the estimation of Activated Partial ThromboplastinTime in plasma/body fluids
44Activated whole blood clotting time tests reagents /kitsClass CA 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.
45Fibrinogen/Fibrin degradation products tests reagents/kitsClass CA Fibrinogen/Fibrin degradation products test reagent/kit is a medical device intended for the estimation of fibrinogen /fibrin degradation products in plasma/body fluids
46D-Dimer tests reagents/kitsClass CA D-Dimer test reagent/kit is a medical device intended for the estimation of D-Dimer test in plasma/body fluids
47Other Reagents/ Kits for estimation of Coagulation parametersClass C
48Reagents/ Kits for monitoring of drug levels used for therapy or abuse exemplified as under   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Aminoglycoside antibiot ics test reagents/kitsClass CAminoglycoside antibiotics test reagents/kits are medical devices intended for the estimation of Aminoglycoside
antibiotics in serum/body fluids.
49Antiepileptics test reagents /kitsClass CAntiepileptics test reagents/kits are medical devices intended for the estimation of Antiepileptics in serum/body fluids.
50Antipsychotics  test reagents /kitsClass CAntipsychotics test reagents/kits are medical devices intended for the  estimation of Antipsychotics in serum/body fluids.
51Mood stabilisers, test reagents /kitsClass CMood stabilisers test reagents/kits are medical devices intended for the estimation of Mood stabilisers in serum /body fluids
52Biologic monoclonal antibody drugs test reagents /kitsClass CBiologic monoclonal antibody drugs test reagents/kits are medical devices intended for the estimation of Biologic monoclonal antibody drugs in serum/body fluids.
53Buprenorphine (BUP) test reagents/kitsClass CBuprenorphine (BUP) test reagents/kits are medical devices intended for the estimation of Buprenorphine (BUP) in serum/body fluids
54Amphetamine (AMP)test reagents/kitsClass CAmphetamine (AMP) test reagents/kits are medical devices intended for the estimation of  Amphetamine (AMP) in serum/body fluids.
55Barbiturates ( BAR) test reagents/kitsClass CBarbiturates ( BAR) test reagents/kits are medical devices intended for the estimation of Barbiturates ( BAR) in serum/body fluids
56Opiate test system test reagents /kitsClass COpiate test reagents/kits are medical devices intended for the estimation of opiates in serum/body fluids
57Benzodiazepines (BZO)Test reagents /kitsClass CBenzodiazepines (BZO) test reagents/kits are medical devices intended for the estimation of Benzodiazepines (BZO) in serum/body fluids
58Cocaine (COC) Test reagents /kitsClass CCocaine (COC) test reagents/kits are medical devices intended for the estimation of Cocaine (COC)in serum/body fluids.
59Cotinine (COT) Test reagents /kitsClass CCotinine (COT) test reagents/kits are medical devices intended for the estimation of Cotinine (COT) in serum/body fluids.
60Ketamine ( KET )Test reagents /kitsClass CKetamine (KET) test reagents/kits are medical devices intended for the estimation of Ketamine ( KET )in serum/body fluids.
61Ecstasy ( MDMA ) Test reagents /kitsClass CEcstasy ( MDMA ) test reagents/kits are medical devices intended for the estimation of Ecstasy ( MDMA )in serum /body fluids
62Methamphetamine (MET ) Test reagents /kitsClass CMethamphetamine ( MET ) test reagents/kits are medical devices intended for the estimation of Methamphetamine (MET) in serum/body fluids
63Morphine ( MOP )Test reagents /kitsClass CMorphine (MOP) test reagents/kits are medical devices intended for the estimation of Morphine (MOP) in serum /body fluids.
64Methaqualone (MQL)Test reagents /kitsClass CMethaqualone (MQL) test reagents/kits are medical devices intended for the estimation of Methaqualone (MQL)in serum/body fluids.
65Methadone ( MTD) Test reagents /kitsClass CMethadone (MTD)test reagents/kits are medical devices intended for the estimation of Methadone ( MTD )in serum /body fluids.
66Oxycodone (OXY)Test reagents /kitsClass COxycodone (OXY) test reagents/kits are medical devices intended for the estimation of Oxycodone (OXY) in serum /body fluids.
67Phencyclidine ( PCP ) Test reagents /kitsClass CPhencyclidine (PCP) test reagents/kits are medical devices intended for the estimation of Phencyclidine (PCP) in serum /body fluids
68Propoxyphene ( PPX ) Test reagents /kitsClass CPropoxyphene (PPX) test reagents/kits are medical devices intended for the estimation of Propoxyphene (PPX) in serum/body fluids
69Tricyclic Antidepressants
(TCA)Test reagents /kits
Class CTricyclic Antidepressants (TCA) test reagents/kits are medical devices intended for the estimation of Tricyclic Antidepressants (TCA) in serum/body fluids
70Marijuana (THC)Test reagents /kitsClass CMarijuana (THC) test reagents/kits are medical devices intended for the estimation of Marijuana (THC) in serum/body fluids
71Tramadol (TRA ) Test reagents /kitsClass CTramadol (TRA) test reagents/kits are medical devices intended for the estimation of Tramadol (TRA) in serum/body fluids
72Fentanyl (FEN)Test reagents /kitsClass CFentanyl (FEN) test reagents/kits are medical devices intended for the estimation of Fentanyl (FEN) in serum/body fluids
73Methadone Metabolite (EDDP)Test reagents /kits.Class CMethadone Metabolite (EDDP) test reagents/kits are medical devices intended for the estimation of Methadone Metabolite ( EDDP )in serum/body fluids
74Other Reagents/ Kits for
monitoring of drug levels used for therapy or abuse
Class C
75Reagents/ Kits for detection of markers for Congenital disorders exemplified as under   

 

Triple Screen Test reagents /kits for Down’s SyndromeClass CTriple Screen Test reagent/kit for Down’s Syndrome is a medical device intended for the screening of Down’s Syndrome in serum/plasma.
76Quadruple Screen Test reagents /kits for Down’s SyndromeClass CQuadruple Screen Test reagent/kit for Down’s Syndrome is a medical device intended for the screening of Down’s Syndrome in serum/plasma
77Chorionic Villus Sample Test reagents/kits for Down’s SyndromeClass CChorionic Villus Sample Test reagent/kit for Down’s Syndrome is a medical device intended for the detection of Down’s Syndrome in body fluids.
78Maternal Serum Alpha-
Fetoprotein (MSAFP) test reagents/kits for spina bifida
Class CMaternal Serum Alpha-Fetoprotein (MSAFP) Test reagents/kits for is a medical device intended for the screening of spina bifida in serum.
79Others Reagents/ Kits for detection of Congenital disordersClass C
80Reagents/ Kits for detection of Cardiac Markers exemplified as underTroponin test reagents/kitsClass CA 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.
81BNP &NT pro BNP test reagents /kits.Class CBNP &NT pro BNP Test reagent/kit for is a medical device intended for theestimation of BNP &NT pro BNP in blood / body fluids.
82Reagents/ Kits for human Genetic testing
exemplified as:
  
Genetic test reagents/kits for Cystic Fibrosis.Class CGenetic test reagent/kit for Cystic Fibrosis is a medical device intended for the detection of Cystic Fibrosis in human specimens.
83Genetic test for Huntington’s choreaClass CGenetic test reagent/kit for Huntington’s chorea is a medical  device intended for the detection of Huntington’s chorea in human specimens.
84Other Reagents/ Kits for human Genetic testingClass C
85Reagents/ Kits for the management of life threatening infections exemplified as under:   

 

 

 

HIV Viral Load test reagents /kits.Class CHIV Viral Load test reagent/kit is a  medical device intended for the estimation of HIV Viral Load in blood/body fluids.
86HBV Viral Load test reagents /kits.Class CHBV Viral Load test reagent/kit is a medical device intended for the estimation of HBV Viral Load in blood/body fluids.
87HCV Viral Load test reagents /kits.Class CHCV Viral Load test reagent/kit is a  medical device intended for the  estimation of HCV Viral Load in blood/body fluids.
88CD4 Count & % test reagents /kitsClass CCD4 Count & % test reagent/kit is a medical device intended for the estimation of CD4 Count & % in blood/body fluids.
89CD8 Count & % test reagents /kitsClass CCD8 Count & % test reagent/kit is a medical device intended for the estimation of CD8 Count & % in blood/body fluids.
90CD4/CD8 Ratio test reagents /kitsClass CCD4/CD8 Ratio test reagent/kit are a medical device intended for the estimation of CD4/CD8 Ratio in blood/body fluids.
91Other Reagents/ Kits for the management of life threatening infectionsClass C
92Reagents/ Kits for the detection of sexually transmitted agent exemplified as under:   

 

 

Treponema pallidum test reagents and kits.Class CTreponema pallidum test reagent/kit is a medical device intended for the detection of Treponema pallidum in blood /body fluids. Ids
93Neisseria gonorrhoeae test reagents and kitsClass CNeisseria gonorrhoeae test reagent/kit is a medical device intended for the detection of Neisseria gonorrhoeae in blood/body fluids.
94Human Papilloma Virus (HPV) test reagents and kitsClass CHuman Papilloma Virus (HPV) test reagent/kit is a medical device intended for the detection of Human Papilloma Virus in blood/body fluids.
95Chlamydia test reagents and kitsClass CChlamydia test reagent/kit is a medical device intended for the detection of Chlamydia in blood/body fluids.
96Herpes Virus test reagents and kitsClass CHerpes Virus test reagent/kit is a medical device intended for the detection of Herpes Virus in blood/body fluids.
97Other Reagents/ Kits for the detection of sexually transmitted agentClass C
98Reagents/ Kits for the Antigen detection of
infectious agents with a risk of limited propagation exemplified as:
   

 

 

 

 

 

 

 

 

 

 

 

 

 

Malaria Antigen test reagents and kitsClass CMalaria Antigen test reagent/kit is a medical device intended for the detection of Malaria Antigen in blood/body fluids.
99Dengue virus Antigen test reagents and kitsClass CDengue virus Antigen test reagent/kit is a medical device intended for the detection of Dengue virus Antigen in blood/body fluids.
100Chikungunya Antigen test reagents and kits.Class CChikungunya Antigen test reagent/kit is a medical device intended for the detection Chikungunya Antigen of in blood/body fluids
101Leptospira Antigen test reagents and kitsClass CLeptospira Antigen test reagent/kit is a medical device intended for the detection of Leptospira Antigen in blood /body fluids.
102Japanese Encephalitis Antigen test reagents and kitsClass CJapanese Encephalitis Antigen test reagent/kit is a medical device intended for the detection of Japanese Encephalitis Antigen in blood/body fluids.
103Typhoid Antigens test reagents and kitsClass CTyphoid Antigens Test reagent/kit is a medical device intended for the detection of Typhoid Antigens in blood/body fluids.
104Influenza A Antigen test reagents and kitsClass CInfluenza A Antigen test reagent/kit is a medical device intended for the detection of Influenza A Antigen in blood /body fluids.
105Influenza B Antigen test reagents and kitsClass CInfluenza B Antigen test reagent/kit is a medical device intended for the detection of Influenza B Antigen in blood /body fluids.
106Strep A Antigen test reagents and kitsClass CStrep A Antigen test reagent/kit is a medical device intended for the detection of Strep A Antigen in blood /body fluids.
107Strep B Antigen test reagents and kitsClass CStrep B test Antigen reagent/kit is a medical device intended for the detection of Strep B Antigen in blood /body fluids
108Chagas Antigen test reagents and kitsClass CChagas disease Antigen test reagent/kit is a medical device  intended for the detection of Chagas disease Antigen in blood/body fluids
109Filariasis Antigen test reagents and kitsClass CFilariasis test Antigen reagent/kit is a medical device intended for the detection of Filariasis Antigen in blood/body fluids
110Kala Azar Antigen test reagents and kits genClass CKala Azar Antigen test reagent/kit is a medical device intended for the detection of Kala Azar Antigen in blood/body fluids
111Rotavirus Antigen test reagents and kitsClass CRotavirus Antigen test reagent/kit is a medical device intended for the detection of Rotavirus Antigen in blood/body fluids.
112S. pneumonia Antigen test reagents and kits.Class CS. pneumonia Antigen test reagent/kit is a medical device  intended for the detection of S. pneumonia Antigen in blood/body fluids.
113H. pylori Antigen Antigen test reagents and kits AntigenClass CH. pylori Antigen test reagent/kit is a medical device intended for the detection of H. pylori Antigen in blood/body fluids
114Other Reagents/ Kits for the detection of infectious agents with a risk of limited propagationClass CReagents/ Kits, other than above, for the Antigen detection of infectious agents with a risk of limited propagation.
115In 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.CategoryIn vitro diagnostic
medical device
Risk ClassIntended use
1In vitro Diagnostic Medical Devices for Blood Grouping or Tissue Typing   

 

 

ABO System test reagents /kitsClass DIntended for blood grouping or tissue typing.
2Rhesus (D) System test reagents /kitsClass D
3The Duffy system test reagents /kitsClass D
4The Kell system test reagents /kitsClass D
5The Kidd system test reagents /kitsClass D
6HLA test reagents/kitsClass D
7Reagents/ Kits for the detection of transmissible agents -screening & confirmatory   

 

HIV test reagents/kitsClass DHIV test reagents/kits is a medical device intended for the detection of HIV in blood/body fluids.
8HBV test reagents/kitsClass DHBV test reagents/kits is a medical device intended for the detection of HBV in blood/body fluids
9HCV test reagents/kitsClass DHCV test reagents/kits is a medical device intended for the detection of HCV in blood/body fluids
10Syphilis screening reagents /kitsClass DSyphilis test reagents/kits is a medical device intended for the screening of Syphilis in blood/body fluids
11Malaria screening reagents /kitsClass DMalaria test reagents/kits is a medical device intended for the screening of Malaria in blood/body fluids

 

S. No.CategoryIn vitro diagnostic
medical device
Risk ClassIntended use
1    Ferritin  test reagents/kitsAn Ferritin test reagent/kit is a medical device intended for the estimation of ferritin in serum /plasma
2Other test reagents/kits for vitaminsTest reagents/kits for the estimation of other than above vitamins in blood/body fluids
3Homocystein test reagents /kitsHomocystein test reagent/kit is a medical device intended for the estimation of Homocystein in blood/body fluids
4allergens test reagents/kitsTest reagents/kits intended for the estimation of allergens in blood/body fluids
5calibrators/controls for above all in
vitro diagnostic medical devices
CalibratorsCalibrators intended to be used with a reagent should be treated in the same class as the In vitro diagnostic medical device reagent.
6ControlsControls intended to be used with a reagent should be treated in the same class as the In vitro diagnostic medical device reagent