Examples of In Vitro Diagnostic Medical Device Classification

Examples of In Vitro Diagnostic Medical Device Classification

Remarks:
  1. Local Responsible Person (LRP) may apply their general medical devices under risk class II/III/IV and in vitro diagnostic medical devices under risk class B/C/D for listing under the Medical Device Administrative Control System (MDACS). For details on application for listing, please refer to Medical Device Listing Application.
  2. The actual classification of a particular device must be considered individually, taking account of its design and use intended by the manufacturer. The above examples of medical devices are for reference only. Please refer to "Classification of General Medical Devices" (Technical Reference TR-003) and "Classification of In Vitro Diagnostic Medical Devices" (Technical Reference TR-006) for details.
  3. Where a medical device has features that place it into more than one class, classification should be based on the highest class indicated.
  4. If there is any inconsistency or ambiguity between the English version and the Chinese version, the English version shall prevail.

* AMDNS = Asian Medical Device Nomenclature System

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Risk Class AExpand
Risk Class A
AMDNS Code* AMDNS Term* Device Description
34062 Analyzers, Laboratory, Mass Spectrometry, Microorganism Identification Laboratory Mass Spectrometers for Microorganism Identification
Risk Class BExpand
Risk Class B
AMDNS Code* AMDNS Term* Device Description
18901 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Albumin Albumin Level Determination Reagents
18930 IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level Alcohol Level Determination Reagents
37125 IVD Test Reagent/Kits, Immunoassay, Alzheimer Disease Alzheimer Disease Diagnostic Reagents
18876 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Amylase Amylase Clinical Chemistry Reagnets
19136 IVD Test Reagent/Kits, Immunoassay, Anemia Test Anemia Test Determination Reagents
17280 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Thyroglobulin Antibody Antithyroglobulin Antibody Test Reagents
19173 IVD Test Reagent/Kits, Immunoassay, Autoimmune Autoimmune Test Reagents (E.g. Rheumatism, Thyroid Gland Immunoassay Test kits)
17058 IVD Test Reagent/Kits, Clinical Chemistry, Control Clinical Chemistry Control Reagents
18884 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Creatine Kinase, Isoenzyme, Muscle-Brain Creatine Kinase Detection Kit/Creatine Kinase Activity Assay Kit
18941 IVD Test Reagent/Kits, Clinical Chemistry, Nitrogen Metabolite, Creatinine Creatinine Determination Reagents
17919 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe, DNA DNA Probe
19113 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone Fertility Hormone Determination Reagents (E.g. Human Chorionic Gonadotropin (HCG) Chemiluminescence - Immuno Assay)
35813 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Glucose-6-PhosphateDehydrogenase G6PD Clinical Chemistry Reagents
18886 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Glutamate Dehydrogenase Glutamate Dehydrogenase (GLUD) Determination Reagents
19204 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Helicobacter pylori Helicobacter pylori Detection/Identification Reagents
19952 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Pregnancy, Human Chorionic Gonadotropin Human Chorionic Gonadotropin Determination Rapid Test Reagents
19666 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe Nucleic Acid Probes
17921 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe, RNA RNA Probe
18960 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum Serum Test Control Reagents
17039 IVD Test Reagent/Kits, Clinical Chemistry, Calibration, Urine Test Urine Test Calibration Reagents
17068 IVD Test Reagent/Kits, Serology, Control, Virus Virus Test Control Reagents
Risk Class CExpand
Risk Class C
AMDNS Code* AMDNS Term* Device Description
19293 IVD Test Reagent/Kits, Hematology, Rapid Test, Activated Partial Thromboplastin Time Activated Partial Thromboplastin Time (APTT) Rapid Test Reagents
17259 IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein AFP (Alpha-Fetoprotein) Determination Reagents
19104 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125 Carbohydrate Antigen CA 125 Immunoassay Reagents
19102 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 15-3 Carbohydrate Antigen CA 15-3 Immunoassay Reagents
19103 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 19-9 Carbohydrate Antigen CA 19-9 Immunoassay Reagents
19278 IVD Test Reagent/Kits, Hematology, Coagulation Factor I (Fibrinogen) Coagulation Factor I (Fibrinogen) Test Reagents
19093 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Creatine Kinase Muscle-Brain Isoenzyme Creatine Kinase Muscle-Brain Isoenzyme Immunoassay Reagents
20044 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Cyclosporine Cyclosporine A (CsA) Drug Level Determination Reagents
19290 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product, D-Dimer D-Dimer Test Reagents
20045 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Tacrolimus FK 506 Immunosupressive Agent Drug Level Determination Reagents
24263 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation Gene Mutation Detection Reagents
19242 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus Genotyping assays for HIV and HCV
16488 Analyzers, Point-of-Care, Whole Blood, Glucose Glucometer; Blood Glucose Meter
17354 IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, IgM Antibody Hepatitis A IgM Antibody Determination Reagents
19123 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin Human Chorionic Gonadotropin (hCG) Determination Reagents
19249 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus Human Papilomarvirus (HPV) diagnostic kit
22310 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Influenza Influenza Virus Determination Reagents
19088 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig, Light Chain, Kappa Kappa Free Light Chain Assay (FLC) Reagents
36690 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Ovarian Cancer Ovarian Tumor Marker Immunoassay Reagents
19053 IVD Test Reagent/Kits, Serology, Virus, Rubella, IgG Antibody Rubella IgG Testing Kit
21515 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, DNA Sexually Transmitted Infections Test Kit
19242 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus Testing reagents for Subtyping of HIV and HCV
19242 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus Testing reagents for Viral load - HCV, HIV
19047 IVD Test Reagent/Kits, Serology, Bacteria, Mycobacterium Species Tuberculosis Rapid Test Kit
20008 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker Tumor Markers Test Reagents
19242 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus Viral Infection Molecular Assay Reagents
37128 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Zika Zika Virus Determination Reagents
Risk Class DExpand
Risk Class D
AMDNS Code* AMDNS Term* Device Description
19295 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing Blood Typing Determination Reagents
19296 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing Blood Typing Determination Reagents
19294 IVD Test Reagent/Kits, Immunohematology, Blood Grouping Blood Typing Determination Reagents
17356 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core Antibody Hepatitis B IgM Core Antibody Determination Reagents
17359 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody Hepatitis B Total Surface Antibody Detection Kit
19060 IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antigen Hepatitis Be Antigen Testing Reagents
17914 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody Hepatitis C Antibody Determination Reagents
19062 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core Antigen Hepatitis C Core Antigen Testing Reagents
19410 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C Hepatitis C Determination Reagents
22291 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis C, RNA Hepatitis C RNA Testing Kit
19245 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV HIV (Human Immunodeficiency Virus) Determination Reagents
19478 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Retrovirus, HIV-1/2 HIV Self Test Kit (Oral Fluid)
19430 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2 Human Immunodeficiency Virus Detection Kit
17360 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen Serology Reagents for Hepatitis B Virus Surface Antigen
19061 IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antibody Serology Reagents for Hepatitis Be Virus Antibody