FDA medical devices classification list

ITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

    - Scope.
    - Effective dates of requirement for premarket approval.
    - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    - Antimicrobial susceptibility test disc.
    - Antimicrobial susceptibility test powder.
    - Fully automated short-term incubation cycle antimicrobial susceptibility system.
    - System for detection of microorganisms and antimicrobial resistance using reporter expression.
    - Culture medium for antimicrobial susceptibility tests.

    - Staphylococcal typing bacteriophage.
    - Anaerobic chamber.
    - Coagulase plasma.
    - Automated colony counter.
    - Manual colony counter.
    - Automated image assessment system for microbial colonies on solid culture media.
    - Multipurpose culture medium.
    - Differential culture medium.
    - Enriched culture medium.
    - Microbiological assay culture medium.
    - Selective culture medium.
    - Transport culture medium.
    - Culture medium for pathogenic Neisseria spp.
    - Oxidase screening test for gonorrhea.
    - Automated medium dispensing and stacking device.
    - Supplement for culture media.
    - Quality control kit for culture media.

   - Microtiter diluting and dispensing device.
    - Microbiological incubator.
    - Microbial growth monitor.
    - Gas-generating device.
    - Wood's fluorescent lamp.
    - Microorganism differentiation and identification device.
    - Streptococcus spp. nucleic acid-based assay.
    - Automated zone reader.
    - Microbiological specimen collection and transport device.

    - Acinetobacter calcoaceticus serological reagents.
    - Adenovirus serological reagents.
    - Arizona spp. serological reagents.
    - Aspergillus spp. serological reagents.
    - In vitro diagnostic device for Bacillus spp. detection.
    - Beta-glucan serological assays.
    - Blastomyces dermatitidis serological reagents.
    - Bordetella spp. serological reagents.
    - Brucella spp. serological reagents.
    - Campylobacter fetus serological reagents.
    - Chlamydia serological reagents.
    - Citrobacter spp. serological reagents.
    - Clostridium difficile toxin gene amplification assay.
    - Coccidioides immitis serological reagents.
    - Corynebacterium spp. serological reagents.
    - Coxsackievirus serological reagents.
    - Cryptococcus neoformans serological reagents.
    - Hepatitis C virus antibody tests.
    - Nucleic acid-based hepatitis C virus ribonucleic acid tests.
    - Cytomegalovirus serological reagents.
    - Echinococcus spp. serological reagents.
    - Echovirus serological reagents.
    - Endotoxin assay.
    - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
    - Entamoeba histolytica serological reagents.
    - Enterovirus nucleic acid assay.
    - Epstein-Barr virus serological reagents.
    - Equine encephalomyelitis virus serological reagents.
    - Erysipelothrix rhusiopathiae serological reagents.
    - Escherichia coli serological reagents.
    - Flavobacterium spp. serological reagents.
    - Francisella tularensis serological reagents.
    - Gonococcal antibody test (GAT).

  - Haemophilus spp. serological reagents.
    - Herpes simplex virus serological assays.
    - Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
    - Hepatitis A virus (HAV) serological assays.
    - Histoplasma capsulatum serological reagents.
    - Influenza virus antigen detection test system.
    - Influenza virus serological reagents.
    - Reagents for detection of specific novel influenza A viruses.
    - John Cunningham Virus serological reagents.
    - Klebsiella spp. serological reagents.
    - Leptospira spp. serological reagents.
    - Listeria spp. serological reagents.
    - Lymphocytic choriomeningitis virus serological reagents.
    - Mass spectrometer system for clinical use for the identification of microorganisms.
    - Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
    - Mycobacterium tuberculosis immunofluorescent reagents.
    - Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
    - Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens.
    - Mycoplasma spp. serological reagents.
    - Mumps virus serological reagents.
    - Neisseria spp. direct serological test reagents.
    - Norovirus serological reagents.
    - Parainfluenza virus serological reagents.
    - Plasmodium species antigen detection assays.
    - Poliovirus serological reagents.
    - Proteus spp. (Weil-Felix) serological reagents.
    - Pseudomonas spp. serological reagents.
    - Rabiesvirus immunofluorescent reagents.
    - Reovirus serological reagents.
    - Respiratory syncytial virus serological reagents.
    - Rhinovirus serological reagents.
    - Rickettsia serological reagents.
    - Rubella virus serological reagents.
    - Rubeola (measles) virus serological reagents.
    - Salmonella spp. serological reagents.
    - Schistosoma spp. serological reagents.
    - Serratia spp. serological reagents.
    - Shigella spp. serological reagents.
    - Sporothrix schenckii serological reagents.
    - Staphylococcus aureus serological reagents.

    - Streptococcus spp. exoenzyme reagents.
    - Streptococcus spp. serological reagents.
    - Toxoplasma gondii serological reagents.
    - Treponema pallidum nontreponemal test reagents.
    - Treponema pallidum treponemal test reagents.
    - Trichinella spiralis serological reagents.
    - Trichomonas vaginalis nucleic acid assay.
    - Trypanosoma spp. serological reagents.
    - Varicella-zoster virus serological reagents.
    - Assayed quality control material for clinical microbiology assays.
    - Vibrio cholerae serological reagents.
    - West Nile virus serological reagents.
    - Dengue virus serological reagents.
    - Dengue virus nucleic acid amplification test reagents.
    - In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
    - Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
    - Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
    - Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
    - Respiratory viral panel multiplex nucleic acid assay.
    - Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
    - Gastrointestinal microorganism multiplex nucleic acid-based assay.

    - RNA Preanalytical Systems.
    - Complement reagent.
    - Immunoelectrophoresis equipment.
    - Immunofluorometer equipment.
    - Immunonephelometer equipment.
    - Ouchterlony agar plate.
    - Automated fluorescence in situ hybridization (FISH) enumeration systems.
    - Automated indirect immunofluorescence microscope and software-assisted system.
    - Radial immunodiffusion plate.
    - Rocket immunoelectrophoresis equipment.
    - Support gel.

    - Albumin immunological test system.
    - Prealbumin immunological test system.
    - Human allotypic marker immunological test system.
    - Alpha-1-antichymotrypsin immunological test system.
    - Antimitochondrial antibody immunological test system.
    - Antinuclear antibody immunological test system.

    - Antiparietal antibody immunological test system.
    - Antismooth muscle antibody immunological test system.
    - Alpha-1-antitrypsin immunological test system.
    - Bence-Jones proteins immunological test system.
    - Beta-globulin immunological test system.
    - Breast milk immunological test system.
    - Fecal calprotectin immunological test system.
    - Carbonic anhydrase B and C immunological test system.
    - Ceruloplasmin immunological test system.
    - Cohn fraction II immunological test system.
    - Colostrum immunological test system.
    - Complement components immunological test system.
    - Complement C1 inhibitor (inactivator) immunological test system.
    - Complement C3b inactivator immunological test system.
    - C-reactive protein immunological test system.
    - Properdin factor B immunological test system.
    - Factor XIII, A, S, immunological test system.
    - Ferritin immunological test system.
    - Fibrinopeptide A immunological test system.
    - Cohn fraction IV immunological test system.
    - Cohn fraction V immunological test system.
    - Free secretory component immunological test system.
    - Alpha-globulin immunological test system.
    - Alpha-1-glycoproteins immunological test system.
    - Alpha-2-glycoproteins immunological test system.
    - Beta-2-glycoprotein I immunological test system.
    - Beta-2-glycoprotein III immunological test system.
    - Haptoglobin immunological test system.
    - Hemoglobin immunological test system.
    - Hemopexin immunological test system.
    - Hypersensitivity pneumonitis immunological test system.
    - Immunoglobulins A, G, M, D, and E immunological test system.
    - Immunoglobulin G (Fab fragment specific) immunological test system.
    - Immunoglobulin G (Fc fragment specific) immunological test system.
    - Immunoglobulin G (Fd fragment specific) immunological test system.
    - Immunoglobulin (light chain specific) immunological test system.
    - Lactic dehydrogenase immunological test system.
    - Lactoferrin immunological test system.
    - Alpha-1-lipoprotein immunological test system.
    - Lipoprotein X immunological test system.
    - Low-density lipoprotein immunological test system.
    - Alpha-2-macroglobulin immunological test system.
    - Beta-2-microglobulin immunological test system.
    - Infectious mononucleosis immunological test system.

    - Multiple autoantibodies immunological test system.
    - Aquaporin-4 autoantibody immunological test system.
    - Zinc transporter 8 autoantibody immunological test system.
    - Myoglobin immunological test system.
    - Whole human plasma or serum immunological test system.
    - Plasminogen immunological test system.
    - Prothrombin immunological test system.
    - Radioallergosorbent (RAST) immunological test system.
    - Tryptase test system.
    - Retinol-binding protein immunological test system.
    - Rheumatoid factor immunological test system.
    - Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
    - Seminal fluid (sperm) immunological test system.
    - Systemic lupus erythematosus immunological test system.
    - Brain trauma assessment test.
    - Total spinal fluid immunological test system.
    - Thyroid autoantibody immunological test system.
    - Transferrin immunological test system.
    - Inter-alpha trypsin inhibitor immunological test system.
    - Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
    - Quality control material for cystic fibrosis nucleic acid assays.
    - Newborn screening test for severe combined immunodeficiency disorder (SCID).
    - Autosomal recessive carrier screening gene mutation detection system.
    - Genetic health risk assessment system.

    - Tumor-associated antigen immunological test system.
    - Immunomagnetic circulating cancer cell selection and enumeration system.
    - AFP-L3% immunological test system.
    - Gene expression profiling test system for breast cancer prognosis.
    - Ovarian adnexal mass assessment score test system.
    - BCR-ABL quantitation test.
    - Next generation sequencing based tumor profiling test.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.