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
20972 Anaerobic Culture Pack/Pouch Kits Anaerobic Culture Kits
15709 Analyzers, Laboratory, Blood Gas/pH Blood Gas Analyzers
18615 Analyzers, Laboratory, Blood, Bilirubin Bilirubin Analyzers
15092 Analyzers, Laboratory, Blood, Urea Nitrogen Blood Urea Nitrogen Analyzers
18613 Analyzers, Laboratory, Body Fluid Body Fluid Analyzers
15089 Analyzers, Laboratory, Body Fluid, Alcohol Alcohol Body Fluid Analyzers
15090 Analyzers, Laboratory, Body Fluid, Amino Acid Amino Acid Analyzers
15100 Analyzers, Laboratory, Body Fluid, Electrolyte Electrolyte Analyzers
15101 Analyzers, Laboratory, Body Fluid, Enzyme Enzyme Analyzers
15102 Analyzers, Laboratory, Body Fluid, Glucose Glucose Analyzers
15103 Analyzers, Laboratory, Body Fluid, Nitrogen Nitrogen Analyzers
17474 Analyzers, Laboratory, Breath Breath Analyzers
15093 Analyzers, Laboratory, Breath, Carbon Monoxide Carbon Monoxide Breath Analyzers
15551 Analyzers, Laboratory, Clinical Chemistry Chemistry Analyzers
16298 Analyzers, Laboratory, Clinical Chemistry, Automated Automated Clinical Chemistry Analyzers
16302 Analyzers, Laboratory, Clinical Chemistry, Manual Manual Clinical Chemistry Analyzers
17740 Analyzers, Laboratory, Hematology Hematology Analyzers
11996 Analyzers, Laboratory, Hematology, Cell Counting, Manual Hemacytometers
15098 Analyzers, Laboratory, Hematology, Coagulation, Automated Automated Coagulation Analyzers
17176 Analyzers, Laboratory, Hematology, Coagulation, Semiautomated Semiautomated Coagulation Analyzers
15177 Analyzers, Laboratory, Hematology, Erythrocyte Sedimentation Rate Sedimentation Rate Units
15146 Analyzers, Laboratory, Hematology, Hemoglobin Hemoglobinometers
18625 Analyzers, Laboratory, Immunoassay Automated Immunoassay Analyzers
17916 Analyzers, Laboratory, Immunoassay, Chemiluminescent chemiluminescent analyser
16218 Analyzers, Laboratory, Immunoassay, Fluorimetric Fluorimetric Immunoassay Analyzers
18627 Analyzers, Laboratory, Immunoassay, Photometric, ELISA Enzyme-Linked Immunosorbent Assay Analyzers
16217 Analyzers, Laboratory, Immunoassay, Photometric, Enzyme (EIA) EIAs
34062 Analyzers, Laboratory, Mass Spectrometry, Microorganism Identification Laboratory Mass Spectrometers for Microorganism Identification
16608 Analyzers, Laboratory, Microbiology Microbiology Analyzers
18630 Analyzers, Laboratory, Microbiology, Blood Culture, Mycobacteria Mycobacteria Blood Culture Analyzers
15091 Analyzers, Laboratory, Microbiology, Susceptibility Antimicrobial Susceptibility Testing System
15306 Analyzers, Laboratory, Microbiology, Susceptibility, Automated Automated Antimicrobial Susceptibility Testing System
16745 Analyzers, Laboratory, Microbiology, Susceptibility, Manual Manual Antimicrobial Susceptibility Testing System
20804 Analyzers, Laboratory, Molecular Assay, Microarray Microarray Analyzers
15301 Analyzers, Laboratory, Radioimmunoassay Radioimmunoassay Analyzers
16382 Analyzers, Laboratory, Radioimmunoassay, Automated Automated Radioimmunoassay Analyzers
16383 Analyzers, Laboratory, Radioimmunoassay, Semiautomated Semiautomated Radioimmunoassay Analyzers
16984 Analyzers, Laboratory, Semen Semen Analysis Systems
16886 Analyzers, Laboratory, Urine Urine Analyzers
16378 Analyzers, Laboratory, Urine, Automated Automated Urine Analyzers
39869 Blood Component Separators, Automated Automated Blood Component Separators
15116 Centrifuges, Floor Floor Centrifuges
10780 Centrifuges, Tabletop Bench-Top Centrifuges
18548 Chambers, Electrophoresis Electrophoresis Chambers
15119 Chromatography Columns Chromatography Columns
15120 Chromatography Systems, Gas Gas Chromatography Systems
15121 Chromatography Systems, Liquid, Packed Column, High-Pressure High-Performance Liquid Chromatography Equipment
28100 Cleaning Solutions, Laboratory Analyzer Washing Solutions
28100 Cleaning Solutions, Laboratory Analyzer Cleaning Solutions
15687 Cover Glass, Microscope Slide Microscope Slide Covers
16582 Cytometers, Automated Automated Cytometers
16867 Cytometers, Automated, Flow Flow Cytometers
16273 Dispensers, Laboratory, Antibiotic Sensitivity Disk Antibiotic Sensitivity Disk Dispensers
15138 Electrophoresis Systems Electrophoresis Equipment
15140 Filter Papers Filter Papers
15149 Immunodiffusion Equipment Immunodiffusion Equipment
35528 IVD Blotters, Nucleic Acid Southern/Northern blot transfer apparatus
19667 IVD Test Reagent/Kits, Electrophoresis, Buffer Electrophoresis Buffer Reagents
19483 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media Culture Media
17451 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Enrichment Microbiology Enrichment Culture Media
19487 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Tube, Agar Culture Media Determination Reagents Agar
19332 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Automated Test Susceptibility Panels
33457 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Manual Test, Minimum Inhibitory Concentration, Strip/Disc CEFTRIAXONE STRIP
33457 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Manual Test, Minimum Inhibitory Concentration, Strip/Disc SPECTINOMYCIN STRIP
33457 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Manual Test, Minimum Inhibitory Concentration, Strip/Disc AZITHROMYCIN STRIP
33457 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Manual Test, Minimum Inhibitory Concentration, Strip/Disc CEFIXIME STRIP
17085 IVD Test Reagent/Kits, Microbiology, Stain Microbiology Staining Reagents
39662 IVD Test Reagent/Kits, Molecular Assay, In Situ Hybridization Chromogenic In Situ Hybridization [CISH] Kits
16823 Microplates Microtiter Plates
15157 Microtomes, Cryostat Cryostat Microtomes
15158 Microtomes, Rotary Rotary Microtomes
15161 Mixers, Clinical Laboratory Clinical Laboratory Blenders
12842 Osmometers Osmometer
12800 Osmometers, Colloid Colloid Osmometers
15701 Petri Dishes Culture Plates
15183 Slide Stainers, Cytology/Histology Cytology/Histology Slide Stainers
15185 Slides, Microscope Microscope Slides
13655 Specimen Containers Specimen Collection Containers
14303 Specimen Containers, Urine Urine Specimen Containers
41633 Specimen Transfer Bags Specimen Transport Bags
15601 Spectrophotometers Spectrophotometers
15188 Tissue Culture Systems Tissue Culture Systems
15190 Tissue Processors Tissue Processors
Risk Class BExpand
Risk Class B
AMDNS Code* AMDNS Term* Device Description
18930 IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level Alcohol Level Determination Reagents
17039 IVD Test Reagent/Kits, Clinical Chemistry, Calibration, Urine Test Urine Test Calibration Reagents
17058 IVD Test Reagent/Kits, Clinical Chemistry, Control Clinical Chemistry Control Reagents
18960 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum Serum Test Control Reagents
18868 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme Enzyme Determination Reagents
18869 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, 5'-Nucleotidase 5'-Nucleotidase Clinical Chemistry Reagents
18870 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Acid Phosphatase Acid Pjosphatase Clinical Chemistry Reagents
18873 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Aldolase Aldolase Clinical Chemistry Reagnets
18876 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Amylase Amylase Clinical Chemistry Reagnets
18884 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Creatine Kinase, Isoenzyme, Muscle-Brain Creatine Kinase Detection Kit/Creatine Kinase Activity Assay Kit
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
18910 IVD Test Reagent/Kits, Clinical Chemistry, Lipid Clinical Chemistry Lipid Reagents
18941 IVD Test Reagent/Kits, Clinical Chemistry, Nitrogen Metabolite, Creatinine Creatinine Determination Reagents
18901 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Albumin Albumin Level Determination Reagents
18908 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Urine Total Urine Protein Clinical Chemistry Reagents
18945 IVD Test Reagent/Kits, Clinical Chemistry, Pyruvate Pyruvate Determination Reagents
20512 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, pH, Strip Litmus papers/ pH test strips
19699 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine, Single Analyte, Strip Urine Test Strips
19273 IVD Test Reagent/Kits, Hematology, Blood Cell Count Blood Cell Count Determination Reagents
19764 IVD Test Reagent/Kits, Hematology, Control, Coagulation, Plasma Plasma Coagulation Test Control Reagents
19675 IVD Test Reagent/Kits, Home Assay, Urine, Bilirubin Bilirubin Determination Reagents
19678 IVD Test Reagent/Kits, Home Assay, Urine, Glucose Glucose Determination Reagents
19679 IVD Test Reagent/Kits, Home Assay, Urine, Ketone Urine Ketone Home-Test Kit Reagents
19681 IVD Test Reagent/Kits, Home Assay, Urine, Occult Blood Urine Occult Blood Determination Reagents
19316 IVD Test Reagent/Kits, Home Assay, Urine, Pregnancy Urine Pregnancy Test Kit
19095 IVD Test Reagent/Kits, Immunoassay, Allergy Allergy Diagnostic Reagents
37125 IVD Test Reagent/Kits, Immunoassay, Alzheimer Disease Alzheimer Disease Diagnostic Reagents
19136 IVD Test Reagent/Kits, Immunoassay, Anemia Test Anemia Test Determination Reagents
19173 IVD Test Reagent/Kits, Immunoassay, Autoimmune Autoimmune Test Reagents (E.g. Rheumatism, Thyroid Gland Immunoassay Test kits)
19174 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Diabetes Diabetes Autoimmune Test Reagents
19177 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic Neurologic Autoimmune Test Reagents
19179 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Rheumatism Rheumatism Autoimmune Test Reagents
17282 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Microsomal Antibody Antimicrosomal Antibody Test Reagents
17280 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Thyroglobulin Antibody Antithyroglobulin Antibody Test Reagents
19888 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker Bone Metabolism Marker Test Reagents
19125 IVD Test Reagent/Kits, Immunoassay, Diabetes Diabetes Diagnostic Reagents (E.g. C-peptide, Insulin ELISA Kit)
19134 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone Endocrine Hormone Detection Kit (E.g. Human Growth Hormone (hGH) ELISA Assay Kit)
19113 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone Fertility Hormone Determination Reagents (E.g. Human Chorionic Gonadotropin (HCG) Chemiluminescence - Immuno Assay)
19331 IVD Test Reagent/Kits, Immunoassay, Immunology Immunology Diagnostic Kits
19702 IVD Test Reagent/Kits, Immunoassay, Lipoprotein Lipoprotein Determination Reagents (E.g. Human Lipoprotein A ELISA Kit)
19949 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Fertility Fertility Test Kit
19952 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Pregnancy, Human Chorionic Gonadotropin Human Chorionic Gonadotropin Determination Rapid Test Reagents
36689 IVD Test Reagent/Kits, Immunoassay, Rheumatism Rheumatism Test Reagents
19108 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone Thyroid Hormone Detection Kit (E.g. Thyroid Stimulating Hormone ELISA Kit)
19204 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Helicobacter pylori Helicobacter pylori Detection/Identification Reagents
19548 IVD Test Reagent/Kits, Microbiology, Control, Fungi/Yeast Test Fungi Test Control Reagents (ASPERGILLUS)
19548 IVD Test Reagent/Kits, Microbiology, Control, Fungi/Yeast Test Fungi Test Control Reagents (BLASTOMYCES）
19548 IVD Test Reagent/Kits, Microbiology, Control, Fungi/Yeast Test Fungi Test Control Reagents （COCCIDIOIDES）
19548 IVD Test Reagent/Kits, Microbiology, Control, Fungi/Yeast Test Fungi Test Control Reagents （HISTOPLASMA）
19666 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe Nucleic Acid Probes
17919 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe, DNA DNA Probe
17921 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe, RNA RNA Probe
17068 IVD Test Reagent/Kits, Serology, Control, Virus Virus Test Control Reagents
22473 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Blastomyces Species, Antigen Blastomyces Detection/Identification Reagents
19442 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Coccidioides immitis Coccidioides immitis Fungi/Yeast Serology Reagents
19449 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Histoplasma capsulatum, Antigen Histoplasma capsulatum Antigen Determination Reagents
19084 IVD Test Reagent/Kits, Serology, Rapid Test, Virus Dengue Virus Antigen Detection (NS1) Kit
22597 IVD Test Reagent/Kits, Skin Test, Allergy Allergy Skin Test Reagents
Risk Class CExpand
Risk Class C
AMDNS Code* AMDNS Term* Device Description
20803 Analyzers, Laboratory, Molecular Assay, Genetic Testing Gene Mutation Analyzers
16749 Analyzers, Point-of-Care, Whole Blood, Coagulation Coagulation Analyzers
16488 Analyzers, Point-of-Care, Whole Blood, Glucose Glucometer; Blood Glucose Meter
35838 IVD Panels, Human Genetics, Aortopathy Aortopathy Gene Panel Reagents (E.g. Aortopathy Panel)
35753 IVD Panels, Human Genetics, Autoimmune Disorder Autoimmune Disorder Gene Panel Reagents (E.g. Rheumatoid Arthritis, Multiple Sclerosis, Systemic Lupus erythematosus panels)
35767 IVD Panels, Human Genetics, Benign Tumor Benign Tumor Gene Panel Reagents (E.g. Tuberous Sclerosis Complex Panel)
35714 IVD Panels, Human Genetics, Blood Disorder Blood Disorder Gene Panel Reagents
35715 IVD Panels, Human Genetics, Blood Disorder, Bleeding Bleeding Gene Panel Reagents
35716 IVD Panels, Human Genetics, Blood Disorder, Bleeding, Platelet-Type Platelet-Type Bleeding Gene Panel Reagents
35727 IVD Panels, Human Genetics, Blood Disorder, Hemolytic Anemia Hemolytic Anemia Gene Panel Reagents
35728 IVD Panels, Human Genetics, Blood Disorder, Hemolytic Anemia, Comprehensive Comprehensive Hemolytic Anemia Gene Panel Reagents
35725 IVD Panels, Human Genetics, Blood Disorder, Hypercholesterolemia Hypercholesterolemia Gene Panel Reagents
35451 IVD Panels, Human Genetics, Bone Disorder Bone Disorder Gene Panel Reagents
35452 IVD Panels, Human Genetics, Bone Disorder, Osteoporosis Osteoporosis Gene Panel Reagents
36673 IVD Panels, Human Genetics, Bone Disorder, Scoliosis Scoliosis Gene Panel Reagents
35459 IVD Panels, Human Genetics, Bone Disorder, Skeletal Dysplasia Skeletal Dysplasia Gene Panel Reagents
35698 IVD Panels, Human Genetics, Bone Marrow Syndrome Bone Marrow Syndrome Gene Panel Reagents
37124 IVD Panels, Human Genetics, Cancer, Familial, Endometrial Familial Endometrial Cancer Gene Panel Reagents
37117 IVD Panels, Human Genetics, Cancer, Familial, Sarcoma Familial Sarcoma Cancer Gene Panel Reagents
36674 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Bladder Bladder Cancer Gene Panel Reagents
36879 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Kidney Tumor Renal Cell Carcinoma Gene Panel Reagents (E.g. Kidney Somatic Cancer Mutation Panel)
36676 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Pancreatic Pancreatic Cancer Gene Panel Reagents (E.g. Pancreatic Somatic Cancer Mutation Panel)
35924 IVD Panels, Human Genetics, Cardiac Disorder Heart Disorder Gene Panel Reagents (E.g. Brugada Syndrome, Long QT syndrome Panel)
35925 IVD Panels, Human Genetics, Cardiac Disorder, Arrhythmia Arrhythmia Gene Panel Reagents
35947 IVD Panels, Human Genetics, Cardiac Disorder, Cardiomyopathy Cardiomyopathy Gene Panel Reagents
35960 IVD Panels, Human Genetics, Cardiac Disorder, Comprehensive Comprehensive Heart Disorder Gene Panel Reagents
36677 IVD Panels, Human Genetics, Comprehensive Comprehensive Human Genetics Panel Reagents (E.g. Whole Genome Sequencing Panel)
35523 IVD Panels, Human Genetics, Encephalopathy Encephalopathy Gene Panel Reagents
35559 IVD Panels, Human Genetics, Encephalopathy, Brain Malformation Brain Malformation Gene Panel Reagents
35560 IVD Panels, Human Genetics, Encephalopathy, Brain Malformation, Comprehensive Comprehensive Brain Malformation Gene Panel Reagents
35548 IVD Panels, Human Genetics, Encephalopathy, Glycine Glycine Gene Panel Reagents
35549 IVD Panels, Human Genetics, Encephalopathy, Glycine, Mutation Glycine Mutation Gene Panel Reagents
35973 IVD Panels, Human Genetics, Eye Disorder Eye Disorder Gene Panel Reagents
35977 IVD Panels, Human Genetics, Eye Disorder, Glaucoma Glaucoma Gene Panel Reagents
35985 IVD Panels, Human Genetics, Eye Disorder, Optic Atrophy Optic Atrophy Gene Panel Reagents
39440 IVD Panels, Human Genetics, Female Infertility Female Reproductive Health Gene Panel Tests
36026 IVD Panels, Human Genetics, Hearing Loss Hearing Loss Gene Panel Reagents
39652 IVD Panels, Human Genetics, Hyperparathyroidism Hyperparathyroidsm Gene Panel Reagents
37464 IVD Panels, Human Genetics, Inflammatory Bowel Disease Inflammatory Bowel Disease Gene Panel Reagents
35758 IVD Panels, Human Genetics, Malignant Hyperthermia Malignant Hyperthermia Gene Panel Reagents
35583 IVD Panels, Human Genetics, Metabolic Disorder Metabolic Disorder Gene Panel Reagents
35682 IVD Panels, Human Genetics, Metabolic Disorder, Albinism Albinism Gene Panel Reagents
35686 IVD Panels, Human Genetics, Metabolic Disorder, Bone Skeletal Metabolic Disorder Gene Panel Reagents
35584 IVD Panels, Human Genetics, Metabolic Disorder, Comprehensive Comprehensive Metabolic Disorder Gene Panel Reagents
35644 IVD Panels, Human Genetics, Metabolic Disorder, Diabetes Diabetes Gene Panel Reagents
35645 IVD Panels, Human Genetics, Metabolic Disorder, Diabetes, Diabetes Mellitus Type 1 Diabetes Mellitus Type 1 Gene Panel Reagents
35635 IVD Panels, Human Genetics, Metabolic Disorder, Epilepsy Epilepsy Gene Panel Reagents
35637 IVD Panels, Human Genetics, Metabolic Disorder, Epilepsy, Mutation Epilepsy Mutation Gene Panel Reagents
35743 IVD Panels, Human Genetics, Migraine Migraine Gene Panel Reagents
36045 IVD Panels, Human Genetics, Mitochondrial Disorder Mitochondrial Disorder Gene Panel Reagents
36046 IVD Panels, Human Genetics, Mitochondrial Disorder, Anemia Anemia Gene Panel Reagents
35774 IVD Panels, Human Genetics, Multisystem Disorder Multisystem Disorder Gene Panel Reagents
36074 IVD Panels, Human Genetics, Neurodegenerative Disorder Neurodegenerative Disorder Gene Panel Reagents
36080 IVD Panels, Human Genetics, Neurodegenerative Disorder, Dementia Dementia Gene Panel Reagents
36098 IVD Panels, Human Genetics, Neuromuscular Disorder Neuromuscular Disorder Gene Panel Reagents
35801 IVD Panels, Human Genetics, Newborn Screening Neonatal Genetic Screening Gene Panel Reagents
35802 IVD Panels, Human Genetics, Newborn Screening, Comprehensive Comprehensive Neonatal Genetic Screening Gene Panel Reagents
35761 IVD Panels, Human Genetics, Overgrowth Syndrome Overgrowth Syndrome Gene Panel Reagents
41062 IVD Panels, Human Genetics, Pancreatitis Pancreatitis Gene Panel Reagents
35763 IVD Panels, Human Genetics, Periodic Fever Syndrome Periodic Fever Syndrome Gene Panel Reagents
36127 IVD Panels, Human Genetics, Peripheral Neuropathy Peripheral Neuropathy Gene Panel Reagents
36680 IVD Panels, Human Genetics, Pharmacogenetic Pharmacogenetic Gene Panel Reagents
37115 IVD Panels, Human Genetics, Pharmacogenetic, Chemotherapeutic Chemotherapeutic Gene Panel Reagents
35804 IVD Panels, Human Genetics, Prenatal Screening Prenatal Genetic Screening Tests
35495 IVD Panels, Human Genetics, Pulmonary Disorder Pulmonary Disorder Gene Panel Reagents
35496 IVD Panels, Human Genetics, Pulmonary Disorder, Comprehensive Comprehensive Pulmonary Disorder Gene Panel Reagents
35501 IVD Panels, Human Genetics, Pulmonary Disorder, Fibrosis Pulmonary Fibrosis Gene Panel Reagents
35505 IVD Panels, Human Genetics, Pulmonary Disorder, Fibrosis, Mutation Pulmonary Fibrosis Mutation Gene Panel Reagents
35514 IVD Panels, Human Genetics, Pulmonary Disorder, Hypertension Pulmonary Hypertension Gene Panel Reagents
35474 IVD Panels, Human Genetics, Renal Disorder Kidney Disorders Gene Panel Reagents
35475 IVD Panels, Human Genetics, Renal Disorder, Comprehensive Comprehensive Kidney Disorders Gene Panel Reagents
35492 IVD Panels, Human Genetics, Renal Disorder, Nephronophthisis Nephronophthisis Gene Panel Reagents
35493 IVD Panels, Human Genetics, Renal Disorder, Nephronophthisis, Mutation Nephronophthisis Mutation Gene Panel Reagents
35691 IVD Panels, Human Genetics, Vascular Malformation Vascular Malformation Gene Panel Reagents
35692 IVD Panels, Human Genetics, Vascular Malformation, Comprehensive Comprehensive Vascular Malformation Gene Panel Reagents
18989 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood Whole Blood Rapid Test Reagents
17052 IVD Test Reagent/Kits, Cytology/Histology, Flow Cytometry Lymphocyte T Cell Population Reagents
17048 IVD Test Reagent/Kits, Hematology, Coagulation Coagulation Determination Reagents
19277 IVD Test Reagent/Kits, Hematology, Coagulation Factor Coagulation Factor Test Reagents
19278 IVD Test Reagent/Kits, Hematology, Coagulation Factor I (Fibrinogen) Coagulation Factor I (Fibrinogen) Test Reagents
19280 IVD Test Reagent/Kits, Hematology, Coagulation Factor IX (Plasma Thromboplastin Component) Coagulation Factor IX (Plasma Thromboplastin Component) Test Reagents
19279 IVD Test Reagent/Kits, Hematology, Coagulation Factor VIII (Antihemolytic Factor) Coagulation Factor VIII (Antihemolytic Factor) Test Reagents
19287 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombophilia Marker Thrombophilia Marker Coagulation Determination Reagents
19288 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombophilia Marker, Platelet Aggregation Platelet Aggregation Determination Reagents
19289 IVD Test Reagent/Kits, Hematology, Fibrinolysis Fibrinolysis Test Reagents
19290 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product, D-Dimer D-Dimer Test Reagents
19773 IVD Test Reagent/Kits, Hematology, Rapid Test Hematology Rapid Test Reagents
19293 IVD Test Reagent/Kits, Hematology, Rapid Test, Activated Partial Thromboplastin Time Activated Partial Thromboplastin Time (APTT) Rapid Test Reagents
19292 IVD Test Reagent/Kits, Hematology, Rapid Test, Prothrombin Time Prothrombin Time (PT) Determination Reagents
19310 IVD Test Reagent/Kits, Home Assay, Whole Blood Whole Blood Home-Test Reagent Kits
39382 IVD Test Reagent/Kits, Immunoassay, Acute Kidney Injury AKI(Acute Kidney Injury) Determination Reagents
19092 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker Cardiac Marker Determination Reagents (E.g. Cardiac Troponin I Human, Creatine Kinase-Myocardial Band (CK-MB) ELISA Kit)
19093 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Creatine Kinase Muscle-Brain Isoenzyme Creatine Kinase Muscle-Brain Isoenzyme Immunoassay Reagents
19123 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin Human Chorionic Gonadotropin (hCG) Determination Reagents
17259 IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein AFP (Alpha-Fetoprotein) Determination Reagents
41965 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Virus Severe Acute Respiratory Syndrome Coronavirus 2, Antibody COVID-19 Rapid Antibody Tests
41964 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Virus Severe Acute Respiratory Syndrome Coronavirus 2, Antigen COVID-19 Rapid Antigen Tests, COVID-19 RAT
20044 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Cyclosporine Cyclosporine A (CsA) Drug Level Determination Reagents
20045 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Tacrolimus FK 506 Immunosupressive Agent Drug Level Determination Reagents
37582 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast Cancer Breast Tumor Marker Immunoassay Reagents
19101 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA Carbohydrate Antigen CA Immunoassay 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
36690 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Ovarian Cancer Ovarian Tumor Marker Immunoassay Reagents
19088 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig, Light Chain, Kappa Kappa Free Light Chain Assay (FLC) Reagents
19089 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig, Light Chain, Lambda Lambda Free Light Chain Assay (FLC) Reagents
20008 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker Tumor Markers Test Reagents
19501 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Clostridium difficile Clostridium difficile Detection/Identification Reagents
19211 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Mycobacterium tuberculosis Mycobacteria tuberculosis Identification Reagents
21743 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Mycobacterium tuberculosis, Antimicrobial-Resistant Antimicrobial-Resistant Mycobacterium tuberculosis Testing Kit
19206 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Treponema pallidum Syphilis Diagnostic Reagents
19522 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Aspergillus Species Aspergillus Detection/Identification Reagents
22346 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Adenovirus Adenovirus Detection/Identification Reagents
19512 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Rotavirus Rotavirus Virus Identification Microbiological Reagents
24077 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Deletion Chromosome Deletion Detection Reagents
19265 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation Chromosome Translocation Detection Kit
24068 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy Trisomy Determination Reagents
19611 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 21, Congenital (Down) Down's Disorder (Trisomy 21) Determination Reagents
24030 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Uniparental Disomy Uniparental Disomy Determination Reagents
24169 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly Gene Anomaly Detection Reagents
24170 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion Gene Deletion Detection Kit
24182 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, Mitochondrial Mitochondrial Gene Deletion Detection Reagents
24263 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation Gene Mutation Detection Reagents
24282 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, AGXT AGXT Enzyme Gene Mutation Detection Reagents
24335 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CFTR CFTR Gene Mutation Detection Reagents
37446 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HTT Huntington Disease Genetic Tests
39662 IVD Test Reagent/Kits, Molecular Assay, In Situ Hybridization Fluorescent In Situ Hybridization [FISH] Kits
21515 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, DNA Sexually Transmitted Infections Test Kit
19560 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Treponema pallidum Syphilis Diagnostic Reagents
19242 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus Testing reagents for Viral load - HCV, HIV
19242 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus Genotyping assays for HIV and HCV
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 Viral Infection Molecular Assay Reagents
22260 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Adenovirus Adenovirus Determination Reagents
22263 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Astrovirus Astrovirus Determination Reagents
41460 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Coronavirus COVID-19 Tests (Laboratory Use)
22277 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Echovirus Echovirus Virus Determination Reagents
22283 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hantavirus Hantavirus Determination Reagents
22285 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis A Hepatitis A Virus Determination Reagents
19247 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Herpes Simplex Herpes Simplex Virus (HSV) Detection Kit
22310 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Influenza Influenza Virus Determination Reagents
22319 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Measles Measles Virus Determination Reagents
37128 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Zika Zika Virus Determination Reagents
36702 IVD Test Reagent/Kits, Molecular Assay, RNA Expression, Cancer Cancer RNA Expression Reagents
36704 IVD Test Reagent/Kits, Molecular Assay, RNA Expression, Cancer, Colon Colon Cancer RNA Expression Reagents (E.g. for Lynch Syndrome)
36706 IVD Test Reagent/Kits, Molecular Assay, RNA Expression, Cancer, Lung Lung Cancer RNA Expression Reagents
36712 IVD Test Reagent/Kits, Molecular Assay, RNA Expression, Cancer, Thyroid Thyroid Cancer RNA Expression Reagents
36714 IVD Test Reagent/Kits, Molecular Assay, RNA Expression, Coronary Artery Disease Coronary Artery Disease RNA Expression Reagents
37603 IVD Test Reagent/Kits, Molecular Assay, Whole Genome Sequencing, Human Whole-Genome Sequencing Reagents
41572 IVD Test Reagent/Kits, Rapid Test, Virus, Severe Acute Respiratory Syndrome Coronavirus 2 COVID-19 Rapid Tests
21813 IVD Test Reagent/Kits, Serology, Bacteria, Leptospira Species, IgM Antibody Serology IVD Test Reagent/Kits for Leptospira Bacteria Antibody
19047 IVD Test Reagent/Kits, Serology, Bacteria, Mycobacterium Species Tuberculosis Rapid Test Kit
19365 IVD Test Reagent/Kits, Serology, Bacteria, Salmonella Species Salmonella Species Detection/Identification Reagents
19440 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Aspergillus Species Aspergillus Species Identification Reagents
17400 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma gondii, Antibody Serology Reagents for Toxoplasma gondii Parasite Antibody
19479 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Cytomegalovirus Cytomegalovirus (CMV) Rapid Test Reagents
19472 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Hepatitis Hepatitis Rapid Test Reagents
20460 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Influenza Influenza Testing Kits
22359 IVD Test Reagent/Kits, Serology, Virus, Astrovirus, Antigen Serology Reagents for Astrovirus Antigen
22385 IVD Test Reagent/Kits, Serology, Virus, Hantavirus, Antibody Serology Reagents for Hantavirus Antibody
17354 IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, IgM Antibody Hepatitis A IgM Antibody Determination Reagents
19063 IVD Test Reagent/Kits, Serology, Virus, Hepatitis D, Antigen Hepatitis D Antigen Testing Reagents
19064 IVD Test Reagent/Kits, Serology, Virus, Hepatitis E, Antibody Hepatitis E Antibody Testing Reagents
19418 IVD Test Reagent/Kits, Serology, Virus, Hepatitis E, IgM Antibody Hepatitis E IgM Antibody Determination Reagents
22406 IVD Test Reagent/Kits, Serology, Virus, Influenza A Serology Reagents for Influenza A Virus
22409 IVD Test Reagent/Kits, Serology, Virus, Influenza A, Antigen Serology Reagents for Influenza A Antigen
22410 IVD Test Reagent/Kits, Serology, Virus, Influenza B Serology Reagents for Influenza B Virus
22413 IVD Test Reagent/Kits, Serology, Virus, Influenza B, Antigen Serology Reagents for Influenza B Antigen
19056 IVD Test Reagent/Kits, Serology, Virus, Influenza, Antibody Influenza Antibody Testing Reagents
22414 IVD Test Reagent/Kits, Serology, Virus, Japanese Encephalitis, IgM Antibody Serology Reagents for Japanese Encephalitis Virus IgM Antibody
19057 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza, Antibody Parainfluenza Antibody Testing Reagents
22427 IVD Test Reagent/Kits, Serology, Virus, Parvovirus B19, Antibody Serology reagents for Virus Parvovirus B19 Antibody
19058 IVD Test Reagent/Kits, Serology, Virus, Respiratory Syncytial Virus Respiratory Syncytial Virus Testing Reagents
19065 IVD Test Reagent/Kits, Serology, Virus, Retrovirus Moloney Murine Leukaemia Virus Detection Kit
19059 IVD Test Reagent/Kits, Serology, Virus, Rotavirus, Antigen Rotavirus Antigen Testing Reagents
19053 IVD Test Reagent/Kits, Serology, Virus, Rubella, IgG Antibody Rubella IgG Testing Kit
17383 IVD Test Reagent/Kits, Serology, Virus, Rubella, IgM Antibody Rubella Virus Antibody-IgM Specific Reagents
22442 IVD Test Reagent/Kits, Serology, Virus, Vaccinia, Antibody Serology Reagents for Vaccinia Antibody
20184 Monitors, Physiologic, Glucose, Personal Portable Blood Glucose Meters
Risk Class DExpand
Risk Class D
AMDNS Code* AMDNS Term* Device Description
19294 IVD Test Reagent/Kits, Immunohematology, Blood Grouping Blood Typing Determination Reagents
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
36670 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RHD Fetal Erythroblastosis Gene Anomaly Detection Reagents
22287 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis B, DNA DNA Molecular Assay Reagents for Hepatitis B Virus Infection
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)
19407 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B Hepatitis B Determination Reagents
17357 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antigen Hepatitis B Core Antigen 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
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
19060 IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antigen Hepatitis Be Antigen Testing Reagents
19410 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C Hepatitis C Determination 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
19430 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2 Human Immunodeficiency Virus Detection Kit
19438 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Virus-I/II HTLV-I/II Determination Reagents