The Regulatory Approval and Classification of In Vitro Diagnostics Rules 2017, was updated by Ministry of Health and Family Welfare, which will come into force on January 1, 2018. This will replace the country’s Drugs and Cosmetics Act for creating effective regulation.

As per the guidelines, In Vitro Diagnostics rules are used for diagnosis in which it is classified based on their level of risk as follows:

  • Class A (low risk)
  • Class B (low moderate risk)
  • Class C (moderate high risk)
  • Class D (high risk)

The In Vitro Diagnostics Rules, 2017, containing the list of IVDs along with their risk based classification was announced in CDSCO Notice dated 29th June 2017.

List of In Vitro Diagnostics with their risk Class:

Currently in Vitro Diagnostic devices (IVDs) for HIV, Hepatitis B & C, Blood Grouping Sera are notified under Drugs & Cosmetics act 1940. In the “In Vitro Diagnostics,2017″ has more types of IVD products which would fall under new notification requirements. IVDs for congenital and autoimmune disorders, genetic testing and sexually transmitted infections would also require notification and IVDs for malaria, dengue, chikungunya, syphilis, typhoid, tuberculosis, cancer markers and blood glucose would require import licenses /performance evaluations in order to obtain market approval in India.

The following is the Classification list of In Vitro Diagnostics along with their risk class.

B. LIST OF IN VITRO DIAGNOSTICS DEVICES ALONG WITH THEIR RISK CLASS
S.No Class Category Medical Device Rules of  In Vitro Diagnostics Intended use
1 Class A Instruments, analyzers, receptacles etc. used for an In Vitro Diagnostics procedure exemplified as : Slides, Mixing sticks, Droppers etc. If it is reagent or an article which possesses any specific characteristic that is intended by its product owner to make it suitable for an In Vitro Diagnostics procedure related to a specific examination
2 Instruments/ Analyzers an instrument intended specifically to be used for an In Vitro Diagnostics procedure
3 Test tubes, Blood collection tubes, Petri dishes etc. a specimen receptacle
4 Class B Clinical Chemistry Reagents/ Kits for estimation of various Parameters exemplified as: Acid Phosphatase (total or prostatic) test reagents/kits An acid phosphatase (total or prostatic) test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of acid phosphatase in serum/plasma.
5 Class B Albumin test reagents/kits An albumin test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of albumin in serum/plasma.
6 Class B Alkaline phosphatase or isoenzymes test reagents/kits An alkaline phosphatase or isoenzymes test reagent/kit is a In Vitro Diagnostics of india intended for the estimation of alkaline phosphatase or its isoenzymes in serum/plasma.
7 Class B Ammonia test reagents/kits An ammonia test reagent/kit is an In Vitro Diagnostics of india in which intended for the estimation of ammonia levels in blood, serum/plasma.
8 Class B Amylase test reagents/kits An amylase test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of the enzyme amylase in serum, saliva / urine.
9 Class B Bicarbonate / carbon dioxide test reagents/kits A bicarbonate/carbon dioxide test reagent/kit In Vitro Diagnostics of india for the estimation of bicarbonate/carbon dioxide in plasma, serum/whole blood.
10 Class B bilirubin (total and direct) test reagents/kits A bilirubin (total and direct) test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of bilirubin (total and direct) in serum/plasma.
11 Class B Calcium test reagents/kits A calcium test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of total calcium in serum.
12 Class B Chloride test reagents/kits A chloride test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of chloride in plasma, serum, sweat /urine.
13 Class B cholesterol (total) test reagents/kits A cholesterol (total) test reagent/kit is a In Vitro Diagnostics of india intended for the estimation of cholesterol in serum or plasma.
14 Class B HDL cholesterol test reagents/kits A HDL cholesterol test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of HDL cholesterol in serum / plasma.
15 Class B LDL cholesterol test reagents/kits A LDL cholesterol test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of LDL cholesterol in serum/plasma.
16 Class B Lipoproteins test reagents/kits A lipoprotein test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of lipoproteins in serum / plasma.
17 Class B Cholinesterase test reagents/kits A cholinesterase test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of cholinesterase in serum /plasma. .
18 Class B Creatine Kinase and its isoenzymestest reagents/kits A creatine phosphokinase/creatine kinase or isoenzymes including CKMB, CKBB and CKMM test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of the enzyme creatine phosphokinase or its isoenzymes in serum / plasma. .
19 Class B Copper test reagents/kits Copper test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of copper in plasma, serum / urine.
20 Class B Creatinine test reagents/kits A creatinine test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of creatinine in serum, plasma / urine.
21 Class B Gamma GlutamylTransferase (GGT) and isoenymes test reagents/kits A Gamma Glutamyl Transferase (GGT) and isoenzymes test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of the enzyme Gamma Glutamyl Transferase
(GGT) in serum / plasma.
22 Class B Glucose test reagents/kits A Glucose test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of glucose in blood/plasma/ body fluids.
23 Class B Glucose-6-Phosphate Dehydrogenase
(G6PD) and its isoenzymes test reagents/kits
A Glucose-6-Phosphate Dehydrogenase (G6PD) test reagents/kit is an In Vitro Diagnostics of india intended for the estimation of Glucose-6-Phosphate Dehydrogenase or its isoenzymes in serum / plasma. .
24 Class B Glycosylated Haemoglobin or its variants test reagents/kits Glycosylated Haemoglobin or its variants test reagents/kits are In Vitro Diagnostics of india intended for the estimation of glycosylated haemoglobin or its variants including A1a, A1b, and A1c in blood.
25 Class B Haemoglobin test reagents/kits A haemoglobin test reagent/kit is an In Vitro Diagnostics  of india intended for the estimation of haemoglobin in blood
26 Class B Iron test reagents/kits An iron test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of iron in serum /plasma.
27 Class B Ferritin test reagents/kits An Ferritin test reagent/kit is an In Vitro Diagnostics  of india intended for the estimation of ferritin in serum / plasma
28 Class B Iron-binding capacity test reagents/kits Iron-binding capacity test reagents/kits are In Vitro Diagnostics of india intended for the estimation of iron-binding capacity in serum / plasma.
29 Class B Lactate Dehydrogenase and its isoenzymes test reagents/kits A Lactate Dehydrogenase and its isoenzymes test reagent/kit is a In Vitro Diagnostics of india intended for the estimation of enzyme Lactate Dehydrogenase and its isoenzymes in serum / plasma.
30 Class B Lipase test reagents/kits A lipase test reagent/kit is an In Vitro Diagnostics of india for the estimation of lipase in serum / plasma.
31 Class B Magnesium test reagents/kits A magnesium test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of magnesium levels in serum / plasma.
32 Class B Phosphorus (inorganic) test reagents/kits A phosphorus (inorganic) test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of inorganic phosphorus in serum,
plasma / urine.
33 Class B Potassium test reagents/kits A potassium test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of potassium in serum, plasma / urine.
34 Class B Aspartate Amino Transferase (AST/SGOT) test reagents/kits An Aspartate Amino Transferase (AST/SGOT) test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of the enzyme Aspartate Aminotransferase (AST/SGOT) in serum / plasma.
35 Class B Alanine Amino Transferase (ALT/SGPT) test reagents/kits An Alanine Amino Transferase (ALT/SGPT) test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of enzyme Alanine Aminotransferase (ALT/SGPT) in serum / plasma.
36 Class B Sodium test reagents/kits A Sodium test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of sodium in serum/ plasma / urine.
37 Class B Total protein test reagents/kits A Total Protein test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of total protein(s) in serum / plasma.
38 Class B Protein (fractionation) test reagents/kits A Protein (fractionation) test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of protein fractions in blood, urine, cerebrospinal fluid / other body fluids.
39 Class B Protein-bound iodine test reagents/kits A Protein-bound iodine test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of protein-bound iodine in serum / plasma.
40 Class B Triglycerides test reagents/kits A Triglyceride test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of triglycerides in serum / plasma.
41 Class B Urea (BUN) test reagents/kits A Urea (BUN) test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of urea/Blood Urea Nitrogen (BUN) in plasma/ serum / urine.
42 Class B Uric Acid test reagents/kits A Uric Acid test reagent/kit is a In Vitro Diagnostics of india intended for the estimation of uric acid in serum/ plasma / urine.
43 Class B Micro-Protein test reagents/kits A Micro-protein test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of micro-proteins including micro-albumin in urine.
44 Class B Zinc test reagents/kits A Zinc test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of zinc in serum / plasma.
45 Class B* Other clinical chemistry test reagents/kits Clinical chemistry test reagent/kit intended for the estimation of analytes/ parameters (other than listed above) in serum/ plasma/ urine or other body fluids.
46 Class B Haematology Reagents/ Kits for estimation of Complete Blood Counts , exemplified as: Blood cell Diluents A blood cell Diluent is an In Vitro Diagnostics of india used to dilute blood for further testing, such as Complete Blood Count (CBC).
47 Class B Lyse reagents/kits for differential counts A Lyse reagent/kit is an In Vitro Diagnostics of india used for lysing of cells for the estimation of Complete Blood Count (CBC).
48 Class B Rinse/Detergent/Cleaners reagents/kits A Rinse/Detergent/Cleaner reagent/kit is an In Vitro Diagnostics of india used for cleaning various parts of Haematology analyzers like probes, needles, baths, tubing etc.
49 Class B 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 Ascorbic Acid/ Bilirubin /Blood Cells/Glucose/ Ketone / Leukocyte peroxidase / Specific gravity/Urobilinogen Nitrite / pH / Protein / Albumin & other urinary analytes test reagents /Strips/kits, are In Vitro Diagnostics  of india intended for the preliminary estimation of diagnostic markers in urine.
50 Class B In – vitro Diagnostic Medical
Devices for Self -Testing
Glucose test reagents/kits A glucose test reagent/kit is a In Vitro Diagnostics  intended for the preliminary self-testing of glucose levels in blood/body fluids.
51 Class B Human Chorionic Gonadotropin (HCG) test reagents/kits A human Chorionic Gonadotropin (HCG) test reagent/kit is an In Vitro Diagnostics of india intended for the preliminary self-testing of HCG in urine/body fluids.
52 Class B Luteinizing Hormone (LH) test reagents/kits A Luteinizing Hormone (LH) test reagent/kit is an In Vitro Diagnostics of india intended for the preliminary self-testing of Luteinizing Hormone (LH) in urine/body fluids.
53 Class B Glycosylated haemoglobin or its variants Test reagents/kits Glycosylated Haemoglobin or its variants test reagents/kits are In Vitro Diagnostics s intended for the preliminary self-testing of Glycosylated Haemoglobin or its variants including A1a, A1b, and A1c in blood.
54 Class B Cholesterol test reagents/kits A Cholesterol test reagent/kit is an In Vitro Diagnostics of india intended for preliminary self-testing of cholesterol in blood /body fluids.
55 Class B Follicle Stimulating Hormone (FSH) test reagents/kits A Follicle Stimulating Hormone
(FSH) test reagent/kit is an In Vitro Diagnostics of india intended for the preliminary self-testing of Follicle Stimulating Hormone (FSH) in urine /body fluids
56 Class B* Other In – vitro Diagnostic In Vitro Diagnostics s for Self -Testing
57 Class c In – vitro Diagnostic In Vitro Diagnostics  for near patient testing Blood Gas Analysis test reagents/kits A Blood Gas Analysis test reagent/kit for near patient testing is an In Vitro Diagnostics of india intended for the estimation of certain gases (such as oxygen and carbon dioxide etc.) dissolved in arterial blood.
58 Class c Anticoagulant monitoring test reagents/kits An Anticoagulant monitoring test reagent/kit for near patient testing is a In Vitro Diagnostics  intended for the estimation of coagulation parameters (such as PT, TT, APTT etc.) in plasma/blood.
59 Class c Diabetes management test reagents/kits A Diabetes management test reagent/kit for near patient testing, is an In Vitro Diagnostics  of india intended for the of monitoring of diabetes in body fluids
60 Class c C- Reactive Protein (CRP)test reagents/kits A C- Reactive Protein (CRP) test reagent/kit for near patient testing, is an In Vitro Diagnostics  of india intended for the estimation of C -Reactive Protein (CRP) in serum and other body fluids
61 Class c H. pylori test reagents/kits An H. pylori test reagent/kit for near patient testing, is an In Vitro Diagnostics of india intended for the estimation of H. pylori in blood/body fluids
62 Class c Troponin test reagents/kits A Troponin test reagent/kit for near patient testing, is an In Vitro Diagnostics of india intended for the estimation of Troponin T,I and its variants in blood/body fluids
63 Class c* Other In Vitro Diagnostics In Vitro Diagnostics s for near patient test reagents/kits In Vitro Diagnostics In Vitro Diagnostics  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.
64 Class C Reagents/ Kits for estimation of parameters of ToRCH& other infectious agents exemplified as under: Toxoplasma gondii test reagents/kits A Toxoplasma gondii test reagent/kit is an In Vitro Diagnostics of india intended for the detection of Toxoplasma gondii in serum/body fluids.
65 Class C Rubella virus l test reagents/kits A Rubella virus test reagent/kit is an In Vitro Diagnostics of india intended for the detection of Rubella virus in serum/body fluids.
66 Class C Cytomegalovirus test reagents/kits A Cytomegalovirus test reagent/kit is an In Vitro Diagnostics of india intended for the detection of Cytomegalovirus in serum/body fluids.
67 Class C Herpes simplex virus reagents/kits A Herpes simplex virus test reagent/kit is an In Vitro Diagnostics intended for the detection of Herpes simplex virus in serum/body fluids.
68 Class C Chlamydia pneumonia test reagents/kits A Chlamydia pneumonia test reagent/kit is an In Vitro Diagnostics intended for the detection of Chlamydia pneumonia in serum/body fluids.
69 Class C Methicillin-Resistant Staphylococcus aureus test reagents/kits A Methicillin-Resistant Staphylococcus aureus test reagent/kit is an In Vitro Diagnostics  intended for the detection of Methicillin-Resistant Staphylococcus aureus in serum/body fluids
70 Class C Enterovirus test reagents/kits An Enterovirus test reagent/kit is an In Vitro Diagnostics  intended for the detection of enterovirus) in serum/body fluids
71 Class C Reagents/ Kits for detection of Cancer Markers exemplified as : Alpha-fetoprotein test reagents/kits An Alpha-fetoprotein test reagent/kit is an In Vitro Diagnostics intended for the detection of Alpha-fetoprotein in serum/body fluids.
72 Class C Beta-2 microglobulin test reagents/kits A Beta-2 microglobulin test reagent/kit is an In Vitro Diagnostics  intended for the detection of Beta-2 microglobulin in serum/body fluids
73 Class C Bladder tumour antigen (BTA) test reagents/kits A Bladder tumour antigen (BTA) test reagent/kit is an In Vitro Diagnostics  intended for the detection of Bladder tumour antigen (BTA)in serum/body fluids
74 Class C CA15-3 test reagents/kits A CA15-3 antigen (BTA) test reagent/kit is an In Vitro Diagnostics  intended for the detection of CA15-3 in serum/body fluids
75 Class C CA27.29 test reagents/kits A CA27.29 test reagent/kit is an In Vitro Diagnostics  intended for the detection of CA27.29 in serum/body fluids
76 Class C CA125 test reagents/kits A CA125test reagent/kit is an In Vitro Diagnostics  intended for the detection of CA125 in serum/body fluids
77 Class C CA72-4 test reagents/kits A CA72-4 test reagent/kit is an In Vitro Diagnostics  intended for the detection of CA72-4 in serum/body fluids
78 Class C CA19-9 test reagents/kits A CA19-9 test reagent/kit is an In Vitro Diagnostics  intended for the detection of CA19-9 in serum/body fluids
79 Class C Calcitonin test reagents/kits A Calcitonin test reagent/kit is an In Vitro Diagnostics  intended for the detection of Calcitonin in serum/body fluids
80 Class C Carcinoembryonic antigen (CEA) test reagents/kits A Carcinoembryonic antigen (CEA) test reagent/kit is an In Vitro Diagnostics  intended for the detection of Carcinoembryonic antigen (CEA) in serum/body fluids
81 Class C Chromogranin A test reagents/kits A Chromogranin A test reagent/kit is an In Vitro Diagnostics  intended for the detection of Chromogranin A in serum/body fluids
82 Class C Estragon / Progesterone receptors test reagents/kits A Estragon / Progesterone test reagent/kit is an In Vitro Diagnostics  intended for the detection of Estragon / Progesterone in serum/body fluids
83 Class C HER2 (Human Epidermal Growth Factor receptor, test reagents/kits A HER2 (Human Epidermal Growth Factor receptor test reagent/kit is an In Vitro Diagnostics  intended for the detection of HER2 (Human Epidermal Growth Factor receptor in serum/body fluids
84 Class C human Chorionic Goadotropin (HCG) test system test reagents/kits A human Chorionic Goadotropin (hCG) test reagent/kit is an In Vitro Diagnostics  intended for the detection of human Chorionic Goadotropin (hCG) in serum/body fluids
85 Class C Lipid associated sialic acid test reagents/kits A Lipid associated sialic acid test reagent/kit is an In Vitro Diagnostics  intended for the detection of Lipid associated sialic acid in serum/body fluids
86 Class C Neuron -Specific Enolase (NSE) test reagents/kits A Neuron -Specific Enolase (NSE) test reagent/kit is an In Vitro Diagnostics  intended for the detection of Neuron -Specific Enolase (NSE) in serum/body fluids
87 Class C NMP22 test reagents/kits A NMP22 test reagent/kit is an In Vitro Diagnostics  intended for the detection of NMP22 in serum/body fluids
88 Class C Prostate-Specific Antigen (PSA) test reagents/kits A Prostate-Specific Antigen (PSA) test reagent/kit is an In Vitro Diagnostics  intended for the detection of Prostate-Specific Antigen (PSA) in serum/body fluids
89 Class C Prostatic Acid Phosphatase (PAP) test reagents/kits A Prostatic Acid Phosphatase (PAP) test reagents/kits
test reagent/kit is an In Vitro Diagnostics  intended for the detection of Prostatic Acid Phosphatase (PAP) test reagents/kits in serum/body fluids
90 Class C Prostate Cancer Antigen 3 gene (PCA 3) test reagents/kits A Prostate Cancer Antigen 3 gene (PCA 3) test reagent/kit is an In Vitro Diagnostics  intended for the detection of Prostate Cancer Antigen 3 gene (PCA 3) in serum/body fluids
91 Class C Prostate-Specific Membrane Antigen (PSMA) test reagents/kits A Prostate-Specific Membrane Antigen (PSMA) test reagent/kit is an In Vitro Diagnostics  intended for the detection of Prostate-Specific Membrane Antigen (PSMA) in serum/body fluids
92 Class C S-100 test reagents/kits A S-100 test reagent/kit is an In Vitro Diagnostics  intended for the detection of S-100 in serum/body fluids
93 Class C TA-90 test reagents/kits A TA-90 test reagent/kit is an In Vitro Diagnostics  intended for the detection of TA-90 in serum/body fluids
94 Class C Thyroglobulin test reagents/kits A Thyroglobulin test reagent/kit is an In Vitro Diagnostics  intended for the detection of Thyroglobulin in serum/body fluids
95 Class C Tissue Polypeptide Antigen (TPA) test reagents/kits A Tissue Polypeptide Antigen (TPA) test reagent/kit is an In Vitro Diagnostics  intended for the detection of Tissue Polypeptide Antigen (TPA) in serum/body fluids
96 Class C* Other Reagents/ Kits for detection of Cancer Markers
97 Class C Reagents/ Kits for estimation of Coagulation parameters exemplified as: PT (Prothrombin Time) test reagents/kits A Prothrombin Time (PT) test reagent/kit is an In Vitro Diagnostics intended for the estimation of prothrombin time in plasma/body fluids.
98 Class C TT (Thrombin Time) test reagents/kits A Thrombin Time(TT)test reagent/kit is an In Vitro Diagnostics  intended for the estimation of Thrombin Time in plasma/body fluids
99 Class C Activated Partial Thromboplastin Time(APTT) tests reagents/kits A Activated Partial ThromboplastinTime (APTT) test reagent/kit is an In Vitro Diagnostics  intended for the estimation of Activated Partial ThromboplastinTime in plasma/body fluids
100 Class C Activated whole blood
clotting time tests
reagents/kits
A Activated whole blood clotting
time test reagent/kit is an IVD intended for the estimation of
Activated whole blood clotting Time
in plasma/body fluids
101 Class C Fibrinogen/Fibrin
degradation products
tests reagents/kits
A Fibrinogen/Fibrin degradation
products test reagent/kit an IVD intended for the estimation of fibrinogen/fibrin degradation products
in plasma/body fluids
102 Class C D-Dimer tests
reagents/kits
A D-Dimer test reagent/kit is an
IVD intended for the estimation of D-Dimer test in
plasma/body fluids
103 Class C* Other Reagents/ Kits for
estimation of
Coagulation parameters
104 Class C Reagents/ Kits for monitoring of drug levels used for therapy or abuse exemplified as under Aminoglycoside antibiotics
test reagents/kits
Aminoglycoside antibiotics test
reagents/kits are IVD is
intended for the estimation of
Aminoglycoside antibiotics in
serum/body fluids.
105 Class C Antiepileptic test
reagents/kits
Antiepileptic test reagents/kits are
IVD is intended for the
estimation of antiepileptic in
serum/body fluids.
106 Class C Antipsychotics test
reagents/kits
Antipsychotics test reagents/kits are
IVD is intended for the
estimation of Antipsychotics in
serum/body fluids.
107 Class C Mood stabilisers, test
reagents/kits
Mood stabilisers test reagents/kits are
IVD is intended for the
estimation of Mood stabilisers in
serum/body fluids
108 Class C Biologic monoclonal
antibody drugs test
reagents/kits
Biologic monoclonal antibody drugs
test reagents/kits are IVD is
intended for the estimation of
Biologic monoclonal antibody drugs
in serum/body fluids
109 Class C Buprenorphine (BUP)
test reagents/kits
Buprenorphine (BUP) test
reagents/kits are IVD is
intended for the estimation of
Buprenorphine (BUP) in serum/body
fluids
110 Class C Amphetamine (AMP)
test reagents/kits
Amphetamine (AMP) test
reagents/kits are IVD is
intended for the estimation of
Amphetamine (AMP) in serum/body
fluids
111 Class C Barbiturates ( BAR)
test reagents/kits
Barbiturates ( BAR) test reagents/kits
are IVD is intended for the
estimation of Barbiturates ( BAR) in
serum/body fluids
112 Class C Opiate test system test
reagents/kits
Opiate test reagents/kits are an IVD intended for the estimation of opiates in serum/body fluids
113 Class C Benzodiazepines
(BZO)Test reagents /kits
Benzodiazepines (BZO) test
reagents/kits are IVD intended for the estimation of
Benzodiazepines (BZO) in
serum/body fluids
114 Class C Cocaine (COC) Test
reagents /kits
Cocaine (COC) test reagents/kits are IVD intended for the estimation of Cocaine (COC)in
serum/body fluids
115 Class C Cotinine (COT) Test
reagents /kits
Cotinine (COT) test reagents/kits are
IVD intended for the
estimation of Cotinine (COT) in
serum/body fluids
116 Class C Ketamine ( KET )Test
reagents /kits
Ketamine (KET) test reagents/kits are
IVD intended for the
estimation of Ketamine ( KET )in
serum/body fluids
117 Class C Ecstasy ( MDMA ) Test
reagents /kits
Ecstasy ( MDMA ) test reagents/kits
are IVD intended for the
estimation of Ecstasy ( MDMA )in
serum/body fluids
118 Class C Methamphetamine (
MET )Test reagents
/kits
Methamphetamine ( MET ) test
reagents/kits are IVD
intended for the estimation of
Methamphetamine (MET) in
serum/body fluids
119 Class C Morphine ( MOP )Test
reagents /kits
Morphine (MOP) test reagents/kits
are IVD intended for the
estimation of Morphine (MOP) in
serum/body fluids
120 Class C Methaqualone
(MQL)Test reagents
/kits
Methaqualone (MQL) test
reagents/kits are IVD
intended for the estimation of
Methaqualone (MQL)in serum/body
fluids
121 Class C Methadone ( MTD) Test
reagents /kits
Methadone (MTD)test reagents/kits
are IVD intended for the
estimation of Methadone ( MTD )in
serum/body fluids
122 Class C Oxycodone (OXY)Test
reagents /kits
Oxycodone (OXY) test reagents/kits
are IVD intended for the
estimation of Oxycodone (OXY) in
serum/body fluids
123 Class C Phencyclidine ( PCP )
Test reagents /kits
Phencyclidine (PCP) test reagents/kits
are IVD intended for the
estimation of Phencyclidine (PCP)in
serum/body fluids
124 Class C Propoxyphene ( PPX )
Test reagents /kits
Propoxyphene (PPX) test
reagents/kits are IVD intended for the estimation of
Propoxyphene (PPX) in serum/body fluids
125 Class C Tricyclic
Antidepressants
(TCA)Test reagents
/kits
Tricyclic Antidepressants (TCA) test
reagents/kits are IVD intended for the estimation of Tricyclic Antidepressants (TCA) in
serum/body fluids
126 Class C Marijuana (THC)Test
reagents /kits
Marijuana (THC) test reagents/kits
are IVD intended for the
estimation of Marijuana (THC) in
serum/body fluids
127 Class C Tramadol (TRA ) Test
reagents /kits
Tramadol (TRA) test reagents/kits are IVD intended for the
estimation of Tramadol (TRA) in
serum/body fluids
128 Class C Fentanyl (FEN)Test
reagents /kits
Fentanyl (FEN) test reagents/kits are IVD intended for the estimation of Fentanyl (FEN) in
serum/body fluids
129 Class C Methadone Metabolite
(EDDP)Test reagents
/kits
Methadone Metabolite (EDDP) test reagents/kits are IVD intended for the estimation of
Methadone Metabolite ( EDDP )in
serum/body fluids
130 Class C* Other Reagents/ Kits for
monitoring of drug
levels used for therapy
or abuse
131 Class B Reagents/ Kits for detection of autoimmune disorders exemplified
as:
Anti-Nuclear Antibodies
test reagents/kits
Anti-Nuclear Antibodies test
reagent/kit is an In Vitro Diagnostics for the
screening of autoantibodies to
nuclear antigens in human specimens
132 Class B Anti Transglutaminase
Antibodies test
reagents/kits
Anti Transglutaminase Antibodies
test reagent/kit is an IVD for the screening of autoantibodies to
Transglutaminase in human
specimens.
133 Class B Anti Ganglioside
Antibodies test
reagents/kits
Anti Ganglioside Antibodies test
reagent/kit is an IVD for the screening of autoantibodies to
Ganglioside in human specimens
134 Class B Anti-Cyclic
Citrullinated Peptide
(CCP) Antibodies test
reagents/kits
Anti-Cyclic Citrullinated Peptide
(CCP) Antibodies test reagent/kit is
an IVD  for the screening of CCP autoantibodies in human
specimens
135 Class B Rheumatoid Factor (RF)
immunological test
reagents/kits
 

Rheumatoid Factor (RF)
immunological test reagent/kit is an
IVD for the screening of
Rheumatoid Factor in human
specimens.

136 Class B Anti-Smooth Muscle
Antibody test
reagents/kits
Anti-Smooth Muscle Antibody test
reagent/kit is an IVD for the
screening of auto-antibodies to
smooth muscles in human specimens
137 Class B Glutamic Acid
Decarboxylase (GAD)
Antibody test
reagents/kits
Glutamic Acid Decarboxylase (GAD)
Antibody test reagent/kit is an IVD for the screening of autoantibodies
to Glutamic Acid
Decarboxylase (in human specimens
138 Class B Anti ovary antibodies
test reagents/kits
Anti ovary antibodies test reagent/kit
is an IVD  for the screening
of auto-antibodies to ovarian antigens
in human specimens
139 Class B Anti-sperm
Antibodies test
reagents/kits
Anti-sperm antibodies test reagent/kit
is an IVD for the screening
of auto-antibodies to spermatozoa in
human specimens.
140 Class B Anti-IA2 test
reagents/kits
Anti-IA-2 antibodies test reagent/kit is
an IVD for the screening of
auto-antibodies to IA-2 (tyrosine
phosphatase) in human specimens
141 Class B Anti-Acetylcholine
Receptor test
reagents/kits
Anti-Acetylcholine Receptor test
reagent/kit is an IVD for the
screening of auto-antibodies to
Acetylcholine Receptor in human
specimens
142 Class B Anti-Thyroid gland
antibody test
reagents/kits
Anti-Thyroid gland antibodies test
reagent/kit is an IVD for the
screening of auto-antibodies to
thyroid gland antigens in human
specimens
143 Class B ANCA test reagents/kits The ANCA test reagent/kit is an
IVD for the screening of
Anti-Neutrophil Cytoplasmic
Antibodies (ANCA) in human
specimens.
144 Class B Anti-double stranded
DNA (anti-dsDNA)test
reagents/kits
The Anti-double stranded DNA
(Anti-dsDNA) test reagent/kit is an IVD  for the screening of
auto-antibodies to Double stranded
DNA in human specimens
145 Class B Anti-Extractable
Nuclear Antigen(Anti-
ENA)test reagents/kits
The Anti-Extractable Nuclear
Antigen (Anti-ENA) test reagent/kit is an IVD for the screening of
auto-antibodies to Extractable
Nuclear Antigens like Smith (Sm)
Antigens, Ribonuclears Protein
(RNP), anti SSA (Ro) etc. in human
specimens.
146 Class B Anti-Intrinsic Factor test
reagents/kits
The Anti-Intrinsic Factor test
reagent/kit is an IVD for
screening of antibodies against the
intrinsic factor in human specimens
147 Class B Anti-Saccharomyces
Cerevisiae Antibodies
(ASCA) test
reagents/kits
The Anti-Saccharomyces
Cerevisiae Antibodies (ASCA) test
reagent/kit is an IVD for the screening of antibodies against
Saccharomyces Cerevisiae in human
specimens.
148 Class B* Other Reagents/ Kits for
detection of
autoimmune disorders
149 Class C Reagents/ Kits for detection of markers for Congenital disorders exemplified as under Triple Screen Test
reagents/kits for Down’s
Syndrome
Triple Screen Test reagent/kit for
Down’s Syndrome an IVD intended for the screening of
Down’s Syndrome in serum/plasma
150 Class C Quadruple Screen Test
reagents/kits for Down’s
Syndrome
Quadruple Screen Test reagent/kit for
Down’s Syndrome is an IVD intended for the screening of
Down’s Syndrome in serum/plasma
151 Class C Chorionic Villus Sample
Test reagents/kits for
Down’s Syndrome
Chorionic Villus Sample Test
reagent/kit for Down’s Syndrome is an
IVD intended for the
detection of Down’s Syndrome in
body fluids.
152 Class C Maternal Serum Alpha-
Fetoprotein (MSAFP)
test reagents/kits for
spina bifida
Maternal Serum Alpha-Fetoprotein
(MSAFP) Test reagents/kits for is an IVD intended for the
screening of spina bifida in serum.
153 Class C* Others Reagents/ Kits
for detection of
Congenital disorders
154 B or C Reagents/ Kits for detection of Cardiac Markers exemplified
as under
155 Class B Creatine Kinase (CK)
and CKMB test
reagents/kits
Creatine Kinase (CK) and CKMB
test reagent/kit is an IVD
intended for the estimation of
Creatine Kinase (CK) and CKMB in
blood / body fluids.
156 Class B Myoglobin test
reagents/kits
Myoglobin Test reagent/kit for is an In Vitro Diagnostics intended for the
estimation of myoglobin in blood
/body fluids.
157 Class C Troponin test
reagents/kits
A Troponin test reagent/kit for near patient testing, is an In Vitro Diagnostics intended for the estimation of
Troponin T,I and its variants in blood
/body fluids
158 Class C BNP &NT pro BNP test
reagents/kits
BNP &NT pro BNP Test reagent/kit
for is an In Vitro Diagnostics  intended for
the estimation of BNP &NT pro
BNP in blood / body fluids
159 Class C Genetic test
reagents/kits for Cystic
Fibrosis
Genetic test reagent/kit for Cystic
Fibrosis is an IVD intended for the detection of Cystic Fibrosis
in human specimens.
160 Class C Genetic test for
Huntington’s chorea
Genetic test reagent/kit for
Huntington’s chorea is a medical
device intended for the detection of
Huntington’s chorea in human
specimens
161 Class C* Other Reagents/ Kits for
human Genetic testing
162 Class C Reagents/ Kits for human Genetic testing exemplified as: Genetic test
reagents/kits for Cystic
Fibrosis
Genetic test reagent/kit for Cystic
Fibrosis is an IVD intended
for the detection of Cystic Fibrosis
in human specimens
163 Class C Genetic test for
Huntington’s chorea
Genetic test reagent/kit for
Huntington’s chorea is a IVD which is intended for the detection of
Huntington’s chorea in human
specimens.
164 Class C* Other Reagents/ Kits for
human Genetic testing
165 Class C Reagents/ Kits for the management of life threatening infections exemplified as under: HIV Viral Load test
reagents/kits
HIV Viral Load test reagent/kit is an IVD intended for the
estimation of HIV Viral Load in
blood/body fluids.
166 Class C HBV Viral Load test
reagents/kits
HBV Viral Load test reagent/kit is an IVD intended for the
estimation of HBV Viral Load in
blood/body fluids.
167 Class C HCV Viral Load test
reagents/kits
HCV Viral Load test reagent/kit is an IVD intended for the
estimation of HCV Viral Load in
blood/body fluids.
168 Class C CD4 Count & % test
reagents/kits
CD4 Count & % test reagent/kit is an IVD intended for the
estimation of CD4 Count & % in
blood/body fluids.
169 Class C CD8 Count & % test
reagents/kits
CD8 Count & % test reagent/kit is an IVD intended for the
estimation of CD8 Count & % in
blood/body fluids.
170 Class C CD4/CD8 Ratio test
reagents/kits
CD4/CD8 Ratio test reagent/kit are an IVD intended for the
estimation of CD4/CD8 Ratio in
blood/body fluids
171 Class C* Other Reagents/ Kits
for the management of
life threatening
infections
172 Class C Reagents/ Kits for the detection of sexually transmitted agent exemplified as under Treponema pallidum
test reagents and kits
Treponema pallidum test reagent/kit is an IVD intended for the
detection of Treponema pallidum in
blood/body fluids.
173 Class C Neisseria gonorrhoeae
test reagents and kits
Neisseria gonorrhoeae test
reagent/kit is an IVD intended for the detection of
Neisseria gonorrhoeae in blood/body
fluids
174 Class C Human Papilloma Virus
(HPV) test reagents and
kits
Human Papilloma Virus (HPV) test
reagent/kit is an IVD intended for the detection of Human
Papilloma Virus in blood/body fluids
175 Class C Chlamydia test reagents
and kits
Chlamydia test reagent/kit is an
IVD  intended for the detection of Chlamydia in
blood/body fluids
176 Class C Herpes Virus test
reagents and kits
Herpes Virus test reagent/kit is an IVD  intended for the
detection of Herpes Virus in
blood/body fluids
177 Class C* Other Reagents/ Kits
for the detection of
sexually transmitted
agent
178 Class C Reagents/ Kits for the Antigen detection of infectious agents with a risk of limited propagation exemplified as: Malaria Antigen test
reagents and kits
Malaria Antigen test reagent/kit is a
regulation of regulatory approval for IVD intended for the
detection of Malaria Antigen in
blood/body fluids
179 Class C Dengue virus Antigen
test reagents and kits
Dengue virus Antigen test
reagent/kit is a regulation of regulatory approval for IVD
intended for the detection of
Dengue virus Antigen in blood/body
fluids
180 Class C Chikungunya Antigen
test reagents and kits
Chikungunya Antigen test
reagent/kit is a regulation of regulatory approval for IVD
intended for the detection
Chikungunya Antigen of in
blood/body fluids
181 Class C Leptospira Antigen test
reagents and kits
Leptospira Antigen test reagent/kit is
a regulation of regulatory approval for
IVD intended for the
detection of Leptospira Antigen in
blood/body fluids
182 Class C Japanese Encephalitis
Antigen test reagents
and kits
Japanese Encephalitis Antigen test
reagent/kit is a regulation of regulatory approval for IVD intended for the detection of
Japanese Encephalitis Antigen in
blood/body fluids
183 Class C Typhoid Antigens test
reagents and kits
Typhoid Antigens Test reagent/kit is a
regulation of regulatory approval for IVD intended for the detection of Typhoid Antigens in
blood/body fluids
184 Class C Influenza A Antigen test
reagents and kits
Influenza A Antigen test reagent/kit is
a regulation of regulatory approval for IVD intended for the detection of Influenza A Antigen in
blood/body fluids
185 Class C Influenza B Antigen test
reagents and kits
Influenza B Antigen test reagent/kit is
a regulation of regulatory approval for
IVD intended for the
detection of Influenza B Antigen in
blood/body fluids
186 Class C Strep A Antigen test
reagents and kits
Strep A Antigen test reagent/kit is a
regulation of regulatory approval for
IVD intended for the
detection of Strep A Antigen in
blood/body fluids
187 Class C Strep B Antigen test
reagents and kits
Strep B test Antigen reagent/kit is a
regulation of regulatory approval for IVD intended for the
detection of Strep B Antigen in
blood/body fluids
188 Class C Chagas Antigen test
reagents and kits
Chagas disease Antigen test
reagent/kit is a regulation of regulatory approval for IVD
intended for the detection of Chagas
disease Antigen in blood/body fluids
189 Class C Filariasis Antigen test
reagents and kits
Filariasis test Antigen reagent/kit is an IVD which is  intended for the detection of Filariasis Antigen in
blood/body fluids
190 Class C Kala Azar Antigen test
reagents and kits gen
Kala Azar Antigen test reagent/kit is a
regulation of regulatory approval for
In Vitro Diagnostics intended for the
detection of Kala Azar Antigen in
blood/body fluids
191 Class C Rotavirus Antigen test
reagents and kits
Rotavirus Antigen test reagent/kit is a
regulation of regulatory approval for
IVD intended for the
detection of Rotavirus Antigen in
blood/body fluids
192 Class C S. pneumonia Antigen
test reagents and kits
S. pneumonia Antigen test
reagent/kit is a regulation of regulatory approval IVD
intended for the detection of S.
pneumonia Antigen in blood/body
fluids
193 Class C H. pylori Antigen
Antigen test reagents
and kits Antigen
H. pylori Antigen test reagent/kit is a
regulation of regulatory approval for
IVD intended for the
detection of H. pylori Antigen in
blood/body fluids
194 Class C* Other Reagents/ Kits for
the detection of
infectious agents with a
risk of limited
propagation
Reagents/ Kits, other than above, for
the Antigen detection of infectious
agents with a risk of limited
propagation
195 Class B 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
Malaria Antibody test reagent/kit is a
regulation of regulatory approval for IVD that are intended for the
detection of Malaria Antibody in
blood/body fluids
196 Class B Dengue Antibody test
reagents and kits
Dengue Antibody test reagent/kit is a regulation of regulatory approval for
IVD which is intended for the
detection of Dengue  Antibody in
blood/body fluids
197 Class B Chikungunya Antibody
test reagents and kits
Chikungunya Antibody test
reagent/kit is a
IVD which is
intended for the detection of
Chikungunya Antibody in
blood/body fluids
198 Class B Leptospira Antibody
test reagents and kits
Leptospira Antibody test reagent/kit
is a regulation of regulatory approval for IVD which is intended for the detection of Leptospira Antibody in
blood/body fluids
199 Class B Japanese Encephalitis
Antibody test reagents
and kits
Japanese Encephalitis Antibody test
reagent/kit is a regulation of regulatory approval for IVD which is
intended for the detection of
Japanese Encephalitis Antibody in
blood/body fluids
200 Class B Typhoid Antibody test
reagents and kits
Typhoid Antibody test reagent/kit is
a regulation of regulatory approval for
IVD which is intended for the
detection of Typhoid Antibody in
blood/body fluids
201 Class B Cryptococcus
neoformans Antibody
test reagents and kits
Cryptococcus neoformans Antibody
test reagent/kit is a regulation of regulatory approval for IVD
intended for the detection of
Cryptococcus neoformans Antibody
in blood/body fluids
202 Class B Neisseria meningitides
Antibody test reagents
and kits
Neisseria meningitides Antibody test
reagent/kit is a regulation of regulatory approval for IVD intended for the detection of
Neisseria meningitides Antibody in
blood/body fluids
203 Class B Vibrio cholera
Antibody test reagents
and kits
Vibrio cholera Antibody test
reagent/kit is a regulation of regulatory approval for IVD which is intended for the detection of Vibrio
cholera Antibody in blood/body
fluids
204 Class B Influenza A Antibody
test reagents and kits
Influenza A Antibody test
reagent/kit is a regulation of regulatory approval for IVD which is intended for the detection of
Influenza A Antibody in
blood/body fluids
205 Class B Influenza B Antibody
test reagents and kits
Influenza B Antibody test
reagent/kit is an IVD which is
intended for the detection of
Influenza B Antibody in
blood/body fluids
206 Class B Strep A Antibody test
reagents and kits
Strep A Antibody test
reagents and kits
207 Class B Strep B Antibody test
reagents and kits
Strep B Antibody test reagents/kits
is a regulation of regulatory approval for
IVD which is intended for the
detection of Strep B Antibody in
blood/body fluids
208 Class B Chagas Antibody test
reagents and kits
Chagas Antibody test reagent/kit is a
regulation of regulatory approval for IVD which is intended for the
detection of Chagas Antibody in
blood/body fluids
209 Class B Filariasis Antibody
test reagents and kits
Filariasis Antibody test reagent/kit is
a regulation of regulatory approval for IVD which is intended for the
detection of Filariasis Antibody
in blood/body fluids
210 Class B Kala Azar Antibody
test reagents and kits
Kala Azar Antibody test
reagents/kits is a regulation of regulatory approval for
IVD which is intended for the detection of Kala
Azar Antibody in blood/body fluids
211 Class B Rotavirus Antibody
test reagents and kits
Rotavirus Antibody test
reagents/kits is a regulation of regulatory approval of
IVD
intended for the detection of
Rotavirus Antibody in blood/body
fluids
212 Class B Rotavirus Antibody
test reagents and kits
Rotavirus Antibody test
reagents/kits is a regulation of regulatory approval for IVD which is
intended for the detection of
Rotavirus Antibody in blood/body
fluids
213 Class B S. pneumonia Antibody
test reagents and kits
S. pneumonia Antibody test
reagent/kit is a regulation of regulatory approval IVD which is intended for the detection of S.
pneumonia Antibody in blood/body
fluids
214 Class B H. pylori Antibody test
reagents and kits
H.pylori Antibody test reagent/kit is a
regulation of regulatory approval for IVD which is intended for the
detection of H.pylori Antibody in
blood/body fluids
215 Class B* Other Reagents/ Kits
for the detection of
Antibodies to infectious
agents with a risk of
limited propagation
216 Class C In Vitro Diagnostics s 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.
217 Class D In Vitro Diagnostics In Vitro Diagnostics s for
Blood Grouping or Tissue Typing
ABO System test
reagents/kits
Intended for blood grouping or tissue
typing.
218 Class D Rhesus (D) System test
reagents/kits
219 Class D The Duffy system test
reagents/kits
220 Class D The Kell system test
reagents/kits
221 Class D The Kell system test
reagents/kits
222 Class D The Kidd system test
reagents/kits
223 Class D HLA test reagents/kits
224 Class D Reagents/ Kits for the detection of
transmissible agents – screening &
confirmatory
HIV test reagents/kits HIV test reagents/kits is a regulation of regulatory approval for IVD which is intended for the detection of
HIV in blood/body fluids.
225 Class D HBV test reagents/kits HBV test reagents/kits is a regulation of regulatory approval for IVD which is  intended for the detection of
HBV in blood/body fluids
226 Class D HCV test reagents/kits HCV test reagents/kits is a regulation of regulatory approval for IVD intended for the detection of
HCV in blood/body fluids
227 Class D Syphilis screening
reagents/kits
Syphilis test reagents/kits is a regulation of regulatory approval for IVD which is
intended for the screening of
Syphilis in blood/body fluids
228 Class D Malaria screening
reagents/kits
Malaria test reagents/kits is a regulation of regulatory approval for IVD which is intended for  screening of
Malaria in blood/body fluids
229 Class B Other in vitro In Vitro Diagnostics s TSH test reagents/kits TSH test reagent/kit is a regulation of regulatory approval for IVD that are intended for the estimation
TSH in blood/body fluids.
230 Class B Total /Free
triiodothyronine (T3)
test reagents/kits
Total /Free triiodothyronine (T3) test
reagent/kit is a regulation of regulatory approval for IVD which is intended for the estimation Total
/Free triiodothyronine (T3) in
blood/body fluids
231 Class B Total / Free thyroxin
(T4) test reagents/kits
Total / Free thyroxin (T4)test
reagent/kit is a regulation of regulatory approval for IVD that are
intended for the estimation of Total /
Free thyroxin (T4)in blood/body
fluids
232 Class B Dehydroepiandrosterone
(DHEA-S) (free and
sulphate) test
reagents/kits
Dehydroepiandrosterone (DHEA-S)
(free and sulphate) test reagent/kit is a
regulation of regulatory approval for IVD which is intended for the
estimation of DHEA-S (free and
sulphate) in blood/body fluids
233 Class B Estragon test
reagents/kits
Estragon test reagent/kit is a regulation of regulatory approval for IVD which is intended for the estimation of
Estragon in blood/body fluids
234 Class B Progesterone test
reagents/kits
Progesterone test reagent/kit is a
regulation of regulatory approval for IVD intended for the
estimation of Progesterone in
blood/body fluids
235 Class B Testosterone (Free and
Total) test reagents/kits
Testosterone (Free and Total) test
reagent/kit is a regulation of regulatory approval for IVD that are intended for the estimation of
Testosterone (Free and Total) in
blood/body fluids
236 Class B Sex Hormone Binding
Globulin (SHBG) test
reagents/kits
Sex Hormone Binding Globulin
(SHBG) test reagent/kit is a regulation of regulatory approval for IVD that are intended for the estimation of
Sex Hormone Binding Globulin
(SHBG) in blood/body fluids
237 Class B Cortisol test
reagents/kits
Cortisol test reagent/kit is a regulation of regulatory approval for IVD which is intended for the estimation of
Cortisol in blood/body fluids
238 Class B Insulin test reagents/kits Insulin test reagent/kit is a regulation of regulatory approval for medical device that are intended for the estimation of
Insulin in blood/body fluids
239 Class B Luteinizing
Hormone(LH) test
reagents/kits
Luteinizing Hormones (LH )test
reagent/kit is a regulation of regulatory approval for medical device which is intended for the estimation of
Luteinizing Hormone (LH) in
blood/body fluids
240 Class B Follicle Stimulating
Hormone(FSH) test
reagents/kits
Follicle Stimulating Hormone (FSH)
test reagent/kit is a regulation of regulatory approval for IVD that is
intended for the estimation of Follicle
Stimulating Hormone(FSH) in  blood/body fluids
241 Class B Prolactin test
reagents/kits
Prolactin test reagent/kit is a regulation of regulatory approval for medical device which is intended for the estimation of
Prolactin in blood/body fluids
242 Class B Other test reagents/kits
for hormones
Test reagents/kits for the estimation
of other than above hormones in
blood/body fluids
243 Class B Vitamin B test
reagents/kits
Vitamin B test reagent/kit is intended for the estimation of Vitamin B in
blood/body fluids
244 Class B Vitamin D test
reagents/kits
Vitamin D test reagent/kit is a regulation of regulatory approval for medical device that is intended for the
estimation of Vitamin B in
blood/body fluids
245 Class B Vitamin A test
reagents/kits
Vitamin A test reagent/kit is a regulation of regulatory approval for medical device which is  intended for the estimation of Vitamin A in
blood/body fluids
246 Class B Vitamin E test
reagents/kits
Vitamin E test reagent/kit is a regulation of regulatory approval for IVD that are intended for the estimation of
Vitamin E in blood/body fluids
247 Class B Vitamin K test
reagents/kits
Vitamin K test reagent/kit is a regulation of regulatory approval for IVD that are intended for the
estimation of Vitamin K in
blood/body fluids
248 Class B Other test reagents/kits
for vitamins
Test reagents/kits for the estimation
of other than above vitamins in
blood/body fluids
249 Class B Homocystein test
reagents/kits
Homocystein test reagent/kit is regulation of regulatory approval for medical device in india which is intended for the estimation of Homocystein in
blood/body fluids
250 Class B allergens test
reagents/kits
Test reagents/kits intended for the
estimation of allergens in blood/body
fluids
251 Class B calibrators/controls for above all in
vitro diagnostic In Vitro Diagnostics s
Calibrators Calibrators is the  regulation of regulatory approval in which it intended to be used with a
reagent that should be treated in the same
class reagent
252 Class B Controls Controls intended to be used with a
reagent should be treated in the same class reagent