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.NoClassCategoryMedical Device Rules of  In Vitro Diagnostics Intended use
1Class AInstruments, 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
2Instruments/ Analyzersan instrument intended specifically to be used for an In Vitro Diagnostics procedure
3Test tubes, Blood collection tubes, Petri dishes etc.a specimen receptacle
4Class BClinical Chemistry Reagents/ Kits for estimation of various Parameters exemplified as:Acid Phosphatase (total or prostatic) test reagents/kitsAn 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.
5Class BAlbumin test reagents/kitsAn albumin test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of albumin in serum/plasma.
6Class BAlkaline phosphatase or isoenzymes test reagents/kitsAn 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.
7Class BAmmonia test reagents/kitsAn ammonia test reagent/kit is an In Vitro Diagnostics of india in which intended for the estimation of ammonia levels in blood, serum/plasma.
8Class BAmylase test reagents/kitsAn amylase test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of the enzyme amylase in serum, saliva / urine.
9Class BBicarbonate / carbon dioxide test reagents/kitsA bicarbonate/carbon dioxide test reagent/kit In Vitro Diagnostics of india for the estimation of bicarbonate/carbon dioxide in plasma, serum/whole blood.
10Class Bbilirubin (total and direct) test reagents/kitsA 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.
11Class BCalcium test reagents/kitsA calcium test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of total calcium in serum.
12Class BChloride test reagents/kitsA chloride test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of chloride in plasma, serum, sweat /urine.
13Class Bcholesterol (total) test reagents/kitsA cholesterol (total) test reagent/kit is a In Vitro Diagnostics of india intended for the estimation of cholesterol in serum or plasma.
14Class BHDL cholesterol test reagents/kitsA HDL cholesterol test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of HDL cholesterol in serum / plasma.
15Class BLDL cholesterol test reagents/kitsA LDL cholesterol test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of LDL cholesterol in serum/plasma.
16Class BLipoproteins test reagents/kitsA lipoprotein test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of lipoproteins in serum / plasma.
17Class BCholinesterase test reagents/kitsA cholinesterase test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of cholinesterase in serum /plasma. .
18Class BCreatine Kinase and its isoenzymestest reagents/kitsA 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. .
19Class BCopper test reagents/kitsCopper test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of copper in plasma, serum / urine.
20Class BCreatinine test reagents/kitsA creatinine test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of creatinine in serum, plasma / urine.
21Class BGamma GlutamylTransferase (GGT) and isoenymes test reagents/kitsA 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.
22Class BGlucose test reagents/kitsA Glucose test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of glucose in blood/plasma/ body fluids.
23Class BGlucose-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. .
24Class BGlycosylated Haemoglobin or its variants test reagents/kitsGlycosylated 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.
25Class BHaemoglobin test reagents/kitsA haemoglobin test reagent/kit is an In Vitro Diagnostics  of india intended for the estimation of haemoglobin in blood
26Class BIron test reagents/kitsAn iron test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of iron in serum /plasma.
27Class BFerritin test reagents/kitsAn Ferritin test reagent/kit is an In Vitro Diagnostics  of india intended for the estimation of ferritin in serum / plasma
28Class BIron-binding capacity test reagents/kitsIron-binding capacity test reagents/kits are In Vitro Diagnostics of india intended for the estimation of iron-binding capacity in serum / plasma.
29Class BLactate Dehydrogenase and its isoenzymes test reagents/kitsA 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.
30Class BLipase test reagents/kitsA lipase test reagent/kit is an In Vitro Diagnostics of india for the estimation of lipase in serum / plasma.
31Class BMagnesium test reagents/kitsA magnesium test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of magnesium levels in serum / plasma.
32Class BPhosphorus (inorganic) test reagents/kitsA phosphorus (inorganic) test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of inorganic phosphorus in serum,
plasma / urine.
33Class BPotassium test reagents/kitsA potassium test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of potassium in serum, plasma / urine.
34Class BAspartate Amino Transferase (AST/SGOT) test reagents/kitsAn 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.
35Class BAlanine Amino Transferase (ALT/SGPT) test reagents/kitsAn 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.
36Class BSodium test reagents/kitsA Sodium test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of sodium in serum/ plasma / urine.
37Class BTotal protein test reagents/kitsA Total Protein test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of total protein(s) in serum / plasma.
38Class BProtein (fractionation) test reagents/kitsA 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.
39Class BProtein-bound iodine test reagents/kitsA Protein-bound iodine test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of protein-bound iodine in serum / plasma.
40Class BTriglycerides test reagents/kitsA Triglyceride test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of triglycerides in serum / plasma.
41Class BUrea (BUN) test reagents/kitsA 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.
42Class BUric Acid test reagents/kitsA Uric Acid test reagent/kit is a In Vitro Diagnostics of india intended for the estimation of uric acid in serum/ plasma / urine.
43Class BMicro-Protein test reagents/kitsA Micro-protein test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of micro-proteins including micro-albumin in urine.
44Class BZinc test reagents/kitsA Zinc test reagent/kit is an In Vitro Diagnostics of india intended for the estimation of zinc in serum / plasma.
45Class B*Other clinical chemistry test reagents/kitsClinical chemistry test reagent/kit intended for the estimation of analytes/ parameters (other than listed above) in serum/ plasma/ urine or other body fluids.
46Class BHaematology Reagents/ Kits for estimation of Complete Blood Counts , exemplified as:Blood cell DiluentsA blood cell Diluent is an In Vitro Diagnostics of india used to dilute blood for further testing, such as Complete Blood Count (CBC).
47Class BLyse reagents/kits for differential countsA Lyse reagent/kit is an In Vitro Diagnostics of india used for lysing of cells for the estimation of Complete Blood Count (CBC).
48Class BRinse/Detergent/Cleaners reagents/kitsA 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.
49Class BReagents/ 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/kitsAscorbic 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.
50Class BIn – vitro Diagnostic Medical
Devices for Self -Testing
Glucose test reagents/kitsA glucose test reagent/kit is a In Vitro Diagnostics  intended for the preliminary self-testing of glucose levels in blood/body fluids.
51Class BHuman Chorionic Gonadotropin (HCG) test reagents/kitsA 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.
52Class BLuteinizing Hormone (LH) test reagents/kitsA 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.
53Class BGlycosylated haemoglobin or its variants Test reagents/kitsGlycosylated 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.
54Class BCholesterol test reagents/kitsA Cholesterol test reagent/kit is an In Vitro Diagnostics of india intended for preliminary self-testing of cholesterol in blood /body fluids.
55Class BFollicle Stimulating Hormone (FSH) test reagents/kitsA 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
56Class B*Other In – vitro Diagnostic In Vitro Diagnostics s for Self -Testing
57Class cIn – vitro Diagnostic In Vitro Diagnostics  for near patient testingBlood Gas Analysis test reagents/kitsA 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.
58Class cAnticoagulant monitoring test reagents/kitsAn 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.
59Class cDiabetes management test reagents/kitsA 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
60Class cC- Reactive Protein (CRP)test reagents/kitsA 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
61Class cH. pylori test reagents/kitsAn 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
62Class cTroponin test reagents/kitsA 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
63Class c*Other In Vitro Diagnostics In Vitro Diagnostics s for near patient test reagents/kitsIn 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.
64Class CReagents/ Kits for estimation of parameters of ToRCH& other infectious agents exemplified as under:Toxoplasma gondii test reagents/kitsA Toxoplasma gondii test reagent/kit is an In Vitro Diagnostics of india intended for the detection of Toxoplasma gondii in serum/body fluids.
65Class CRubella virus l test reagents/kitsA Rubella virus test reagent/kit is an In Vitro Diagnostics of india intended for the detection of Rubella virus in serum/body fluids.
66Class CCytomegalovirus test reagents/kitsA Cytomegalovirus test reagent/kit is an In Vitro Diagnostics of india intended for the detection of Cytomegalovirus in serum/body fluids.
67Class CHerpes simplex virus reagents/kitsA Herpes simplex virus test reagent/kit is an In Vitro Diagnostics intended for the detection of Herpes simplex virus in serum/body fluids.
68Class CChlamydia pneumonia test reagents/kitsA Chlamydia pneumonia test reagent/kit is an In Vitro Diagnostics intended for the detection of Chlamydia pneumonia in serum/body fluids.
69Class CMethicillin-Resistant Staphylococcus aureus test reagents/kitsA 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
70Class CEnterovirus test reagents/kitsAn Enterovirus test reagent/kit is an In Vitro Diagnostics  intended for the detection of enterovirus) in serum/body fluids
71Class CReagents/ Kits for detection of Cancer Markers exemplified as :Alpha-fetoprotein test reagents/kitsAn Alpha-fetoprotein test reagent/kit is an In Vitro Diagnostics intended for the detection of Alpha-fetoprotein in serum/body fluids.
72Class CBeta-2 microglobulin test reagents/kitsA Beta-2 microglobulin test reagent/kit is an In Vitro Diagnostics  intended for the detection of Beta-2 microglobulin in serum/body fluids
73Class CBladder tumour antigen (BTA) test reagents/kitsA 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
74Class CCA15-3 test reagents/kitsA CA15-3 antigen (BTA) test reagent/kit is an In Vitro Diagnostics  intended for the detection of CA15-3 in serum/body fluids
75Class CCA27.29 test reagents/kitsA CA27.29 test reagent/kit is an In Vitro Diagnostics  intended for the detection of CA27.29 in serum/body fluids
76Class CCA125 test reagents/kitsA CA125test reagent/kit is an In Vitro Diagnostics  intended for the detection of CA125 in serum/body fluids
77Class CCA72-4 test reagents/kitsA CA72-4 test reagent/kit is an In Vitro Diagnostics  intended for the detection of CA72-4 in serum/body fluids
78Class CCA19-9 test reagents/kitsA CA19-9 test reagent/kit is an In Vitro Diagnostics  intended for the detection of CA19-9 in serum/body fluids
79Class CCalcitonin test reagents/kitsA Calcitonin test reagent/kit is an In Vitro Diagnostics  intended for the detection of Calcitonin in serum/body fluids
80Class CCarcinoembryonic antigen (CEA) test reagents/kitsA Carcinoembryonic antigen (CEA) test reagent/kit is an In Vitro Diagnostics  intended for the detection of Carcinoembryonic antigen (CEA) in serum/body fluids
81Class CChromogranin A test reagents/kitsA Chromogranin A test reagent/kit is an In Vitro Diagnostics  intended for the detection of Chromogranin A in serum/body fluids
82Class CEstragon / Progesterone receptors test reagents/kitsA Estragon / Progesterone test reagent/kit is an In Vitro Diagnostics  intended for the detection of Estragon / Progesterone in serum/body fluids
83Class CHER2 (Human Epidermal Growth Factor receptor, test reagents/kitsA 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
84Class Chuman Chorionic Goadotropin (HCG) test system test reagents/kitsA 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
85Class CLipid associated sialic acid test reagents/kitsA 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
86Class CNeuron -Specific Enolase (NSE) test reagents/kitsA 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
87Class CNMP22 test reagents/kitsA NMP22 test reagent/kit is an In Vitro Diagnostics  intended for the detection of NMP22 in serum/body fluids
88Class CProstate-Specific Antigen (PSA) test reagents/kitsA 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
89Class CProstatic Acid Phosphatase (PAP) test reagents/kitsA 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
90Class CProstate Cancer Antigen 3 gene (PCA 3) test reagents/kitsA 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
91Class CProstate-Specific Membrane Antigen (PSMA) test reagents/kitsA 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
92Class CS-100 test reagents/kitsA S-100 test reagent/kit is an In Vitro Diagnostics  intended for the detection of S-100 in serum/body fluids
93Class CTA-90 test reagents/kitsA TA-90 test reagent/kit is an In Vitro Diagnostics  intended for the detection of TA-90 in serum/body fluids
94Class CThyroglobulin test reagents/kitsA Thyroglobulin test reagent/kit is an In Vitro Diagnostics  intended for the detection of Thyroglobulin in serum/body fluids
95Class CTissue Polypeptide Antigen (TPA) test reagents/kitsA 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
96Class C*Other Reagents/ Kits for detection of Cancer Markers
97Class CReagents/ Kits for estimation of Coagulation parameters exemplified as:PT (Prothrombin Time) test reagents/kitsA Prothrombin Time (PT) test reagent/kit is an In Vitro Diagnostics intended for the estimation of prothrombin time in plasma/body fluids.
98Class CTT (Thrombin Time) test reagents/kitsA Thrombin Time(TT)test reagent/kit is an In Vitro Diagnostics  intended for the estimation of Thrombin Time in plasma/body fluids
99Class CActivated Partial Thromboplastin Time(APTT) tests reagents/kitsA Activated Partial ThromboplastinTime (APTT) test reagent/kit is an In Vitro Diagnostics  intended for the estimation of Activated Partial ThromboplastinTime in plasma/body fluids
100Class CActivated 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
101Class CFibrinogen/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
102Class CD-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
103Class C*Other Reagents/ Kits for
estimation of
Coagulation parameters
104Class CReagents/ Kits for monitoring of drug levels used for therapy or abuse exemplified as underAminoglycoside antibiotics
test reagents/kits
Aminoglycoside antibiotics test
reagents/kits are IVD is
intended for the estimation of
Aminoglycoside antibiotics in
serum/body fluids.
105Class CAntiepileptic test
reagents/kits
Antiepileptic test reagents/kits are
IVD is intended for the
estimation of antiepileptic in
serum/body fluids.
106Class CAntipsychotics test
reagents/kits
Antipsychotics test reagents/kits are
IVD is intended for the
estimation of Antipsychotics in
serum/body fluids.
107Class CMood stabilisers, test
reagents/kits
Mood stabilisers test reagents/kits are
IVD is intended for the
estimation of Mood stabilisers in
serum/body fluids
108Class CBiologic 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
109Class CBuprenorphine (BUP)
test reagents/kits
Buprenorphine (BUP) test
reagents/kits are IVD is
intended for the estimation of
Buprenorphine (BUP) in serum/body
fluids
110Class CAmphetamine (AMP)
test reagents/kits
Amphetamine (AMP) test
reagents/kits are IVD is
intended for the estimation of
Amphetamine (AMP) in serum/body
fluids
111Class CBarbiturates ( BAR)
test reagents/kits
Barbiturates ( BAR) test reagents/kits
are IVD is intended for the
estimation of Barbiturates ( BAR) in
serum/body fluids
112Class COpiate test system test
reagents/kits
Opiate test reagents/kits are an IVD intended for the estimation of opiates in serum/body fluids
113Class CBenzodiazepines
(BZO)Test reagents /kits
Benzodiazepines (BZO) test
reagents/kits are IVD intended for the estimation of
Benzodiazepines (BZO) in
serum/body fluids
114Class CCocaine (COC) Test
reagents /kits
Cocaine (COC) test reagents/kits are IVD intended for the estimation of Cocaine (COC)in
serum/body fluids
115Class CCotinine (COT) Test
reagents /kits
Cotinine (COT) test reagents/kits are
IVD intended for the
estimation of Cotinine (COT) in
serum/body fluids
116Class CKetamine ( KET )Test
reagents /kits
Ketamine (KET) test reagents/kits are
IVD intended for the
estimation of Ketamine ( KET )in
serum/body fluids
117Class CEcstasy ( MDMA ) Test
reagents /kits
Ecstasy ( MDMA ) test reagents/kits
are IVD intended for the
estimation of Ecstasy ( MDMA )in
serum/body fluids
118Class CMethamphetamine (
MET )Test reagents
/kits
Methamphetamine ( MET ) test
reagents/kits are IVD
intended for the estimation of
Methamphetamine (MET) in
serum/body fluids
119Class CMorphine ( MOP )Test
reagents /kits
Morphine (MOP) test reagents/kits
are IVD intended for the
estimation of Morphine (MOP) in
serum/body fluids
120Class CMethaqualone
(MQL)Test reagents
/kits
Methaqualone (MQL) test
reagents/kits are IVD
intended for the estimation of
Methaqualone (MQL)in serum/body
fluids
121Class CMethadone ( MTD) Test
reagents /kits
Methadone (MTD)test reagents/kits
are IVD intended for the
estimation of Methadone ( MTD )in
serum/body fluids
122Class COxycodone (OXY)Test
reagents /kits
Oxycodone (OXY) test reagents/kits
are IVD intended for the
estimation of Oxycodone (OXY) in
serum/body fluids
123Class CPhencyclidine ( PCP )
Test reagents /kits
Phencyclidine (PCP) test reagents/kits
are IVD intended for the
estimation of Phencyclidine (PCP)in
serum/body fluids
124Class CPropoxyphene ( PPX )
Test reagents /kits
Propoxyphene (PPX) test
reagents/kits are IVD intended for the estimation of
Propoxyphene (PPX) in serum/body fluids
125Class CTricyclic
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
126Class CMarijuana (THC)Test
reagents /kits
Marijuana (THC) test reagents/kits
are IVD intended for the
estimation of Marijuana (THC) in
serum/body fluids
127Class CTramadol (TRA ) Test
reagents /kits
Tramadol (TRA) test reagents/kits are IVD intended for the
estimation of Tramadol (TRA) in
serum/body fluids
128Class CFentanyl (FEN)Test
reagents /kits
Fentanyl (FEN) test reagents/kits are IVD intended for the estimation of Fentanyl (FEN) in
serum/body fluids
129Class CMethadone 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
130Class C*Other Reagents/ Kits for
monitoring of drug
levels used for therapy
or abuse
131Class BReagents/ 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
132Class BAnti Transglutaminase
Antibodies test
reagents/kits
Anti Transglutaminase Antibodies
test reagent/kit is an IVD for the screening of autoantibodies to
Transglutaminase in human
specimens.
133Class BAnti Ganglioside
Antibodies test
reagents/kits
Anti Ganglioside Antibodies test
reagent/kit is an IVD for the screening of autoantibodies to
Ganglioside in human specimens
134Class BAnti-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
135Class BRheumatoid 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.

136Class BAnti-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
137Class BGlutamic 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
138Class BAnti 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
139Class BAnti-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.
140Class BAnti-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
141Class BAnti-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
142Class BAnti-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
143Class BANCA test reagents/kitsThe ANCA test reagent/kit is an
IVD for the screening of
Anti-Neutrophil Cytoplasmic
Antibodies (ANCA) in human
specimens.
144Class BAnti-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
145Class BAnti-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.
146Class BAnti-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
147Class BAnti-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.
148Class B*Other Reagents/ Kits for
detection of
autoimmune disorders
149Class CReagents/ Kits for detection of markers for Congenital disorders exemplified as underTriple 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
150Class CQuadruple 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
151Class CChorionic 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.
152Class CMaternal 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.
153Class C*Others Reagents/ Kits
for detection of
Congenital disorders
154B or CReagents/ Kits for detection of Cardiac Markers exemplified
as under
155Class BCreatine 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.
156Class BMyoglobin test
reagents/kits
Myoglobin Test reagent/kit for is an In Vitro Diagnostics intended for the
estimation of myoglobin in blood
/body fluids.
157Class CTroponin 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
158Class CBNP &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
159Class CGenetic 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.
160Class CGenetic 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
161Class C*Other Reagents/ Kits for
human Genetic testing
162Class CReagents/ 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
163Class CGenetic 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.
164Class C*Other Reagents/ Kits for
human Genetic testing
165Class CReagents/ 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.
166Class CHBV 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.
167Class CHCV 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.
168Class CCD4 Count & % test
reagents/kits
CD4 Count & % test reagent/kit is an IVD intended for the
estimation of CD4 Count & % in
blood/body fluids.
169Class CCD8 Count & % test
reagents/kits
CD8 Count & % test reagent/kit is an IVD intended for the
estimation of CD8 Count & % in
blood/body fluids.
170Class CCD4/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
171Class C*Other Reagents/ Kits
for the management of
life threatening
infections
172Class CReagents/ Kits for the detection of sexually transmitted agent exemplified as underTreponema pallidum
test reagents and kits
Treponema pallidum test reagent/kit is an IVD intended for the
detection of Treponema pallidum in
blood/body fluids.
173Class CNeisseria gonorrhoeae
test reagents and kits
Neisseria gonorrhoeae test
reagent/kit is an IVD intended for the detection of
Neisseria gonorrhoeae in blood/body
fluids
174Class CHuman 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
175Class CChlamydia test reagents
and kits
Chlamydia test reagent/kit is an
IVD  intended for the detection of Chlamydia in
blood/body fluids
176Class CHerpes Virus test
reagents and kits
Herpes Virus test reagent/kit is an IVD  intended for the
detection of Herpes Virus in
blood/body fluids
177Class C*Other Reagents/ Kits
for the detection of
sexually transmitted
agent
178Class CReagents/ 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
179Class CDengue 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
180Class CChikungunya 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
181Class CLeptospira 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
182Class CJapanese 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
183Class CTyphoid 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
184Class CInfluenza 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
185Class CInfluenza 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
186Class CStrep 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
187Class CStrep 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
188Class CChagas 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
189Class CFilariasis 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
190Class CKala 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
191Class CRotavirus 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
192Class CS. 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
193Class CH. 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
194Class 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
195Class BReagents/ 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
196Class BDengue 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
197Class BChikungunya 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
198Class BLeptospira 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
199Class BJapanese 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
200Class BTyphoid 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
201Class BCryptococcus
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
202Class BNeisseria 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
203Class BVibrio 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
204Class BInfluenza 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
205Class BInfluenza 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
206Class BStrep A Antibody test
reagents and kits
Strep A Antibody test
reagents and kits
207Class BStrep 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
208Class BChagas 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
209Class BFilariasis 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
210Class BKala 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
211Class BRotavirus 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
212Class BRotavirus 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
213Class BS. 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
214Class BH. 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
215Class B*Other Reagents/ Kits
for the detection of
Antibodies to infectious
agents with a risk of
limited propagation
216Class CIn Vitro Diagnostics s for Blood Grouping or Tissue TypingAll other than,
the ABO system;
the Duffy system;
the Kell system;
the Kidd system;
the Rhesus system,
test reagents/kits.
217Class DIn Vitro Diagnostics In Vitro Diagnostics s for
Blood Grouping or Tissue Typing
ABO System test
reagents/kits
Intended for blood grouping or tissue
typing.
218Class DRhesus (D) System test
reagents/kits
219Class DThe Duffy system test
reagents/kits
220Class DThe Kell system test
reagents/kits
221Class DThe Kell system test
reagents/kits
222Class DThe Kidd system test
reagents/kits
223Class DHLA test reagents/kits
224Class DReagents/ Kits for the detection of
transmissible agents – screening &
confirmatory
HIV test reagents/kitsHIV test reagents/kits is a regulation of regulatory approval for IVD which is intended for the detection of
HIV in blood/body fluids.
225Class DHBV test reagents/kitsHBV test reagents/kits is a regulation of regulatory approval for IVD which is  intended for the detection of
HBV in blood/body fluids
226Class DHCV test reagents/kitsHCV test reagents/kits is a regulation of regulatory approval for IVD intended for the detection of
HCV in blood/body fluids
227Class DSyphilis 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
228Class DMalaria 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
229Class BOther in vitro In Vitro Diagnostics sTSH test reagents/kitsTSH test reagent/kit is a regulation of regulatory approval for IVD that are intended for the estimation
TSH in blood/body fluids.
230Class BTotal /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
231Class BTotal / 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
232Class BDehydroepiandrosterone
(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
233Class BEstragon 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
234Class BProgesterone 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
235Class BTestosterone (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
236Class BSex 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
237Class BCortisol 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
238Class BInsulin test reagents/kitsInsulin test reagent/kit is a regulation of regulatory approval for medical device that are intended for the estimation of
Insulin in blood/body fluids
239Class BLuteinizing
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
240Class BFollicle 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
241Class BProlactin 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
242Class BOther test reagents/kits
for hormones
Test reagents/kits for the estimation
of other than above hormones in
blood/body fluids
243Class BVitamin B test
reagents/kits
Vitamin B test reagent/kit is intended for the estimation of Vitamin B in
blood/body fluids
244Class BVitamin 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
245Class BVitamin 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
246Class BVitamin 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
247Class BVitamin 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
248Class BOther test reagents/kits
for vitamins
Test reagents/kits for the estimation
of other than above vitamins in
blood/body fluids
249Class BHomocystein 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
250Class Ballergens test
reagents/kits
Test reagents/kits intended for the
estimation of allergens in blood/body
fluids
251Class Bcalibrators/controls for above all in
vitro diagnostic In Vitro Diagnostics s
CalibratorsCalibrators 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
252Class BControlsControls intended to be used with a
reagent should be treated in the same class reagent