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IVD Classification System: 2018

IVD Classification System: 2018

In India, In -Vitro Diagnostic kits/reagents are regulated under the provisions of the Medical Device Rules, 2017.

IVD’s are defined as substances intended to be used outside human or animal bodies for the diagnosis of any disease or disorder in human beings or animals covered under sub-clause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and IVDs that are notified, from time to time, as a device under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940.

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

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