21 C.F.R. PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval.
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--DIAGNOSTIC DEVICES
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| Antimicrobial susceptibility test disc.
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| Antimicrobial susceptibility test powder.
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| Fully automated short-term incubation cycle antimicrobial susceptibility system.
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| Culture medium for antimicrobial susceptibility tests.
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Subpart C--MICROBIOLOGY DEVICES
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| Staphylococcal typing bacteriophage.
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| Automated colony counter.
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| Multipurpose culture medium.
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| Differential culture medium.
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| Microbiological assay culture medium.
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| Selective culture medium.
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| Transport culture medium.
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| Culture medium for pathogenic spp.
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| Oxidase screening test for gonorrhea.
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| Automated medium dispensing and stacking device.
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| Supplement for culture media.
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| Quality control kit for culture media.
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| Microtiter diluting and dispensing device.
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| Microbiological incubator.
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| Microbial growth monitor.
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| Microorganism differentiation and identification device.
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| Microbiological specimen collection and transport device.
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Subpart D--SEROLOGICAL REAGENTS
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| Adenovirus serological reagents.
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| spp. serological reagents.
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| spp. serological reagents.
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| Beta-glucan serological assays.
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| spp. serological reagents.
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| spp. serological reagents.
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| Chlamydia serological reagents.
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| spp. serological reagents.
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| spp. serological reagents.
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| Coxsackievirus serological reagents.
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| Cytomegalovirus serological reagents.
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| spp. serological reagents.
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| Echovirus serological reagents.
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| Epstein-Barr virus serological reagents.
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| Equine encephalomyelitis virus serological reagents.
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| spp. serological reagents.
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| Gonococcal antibody test (GAT).
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| spp. serological reagents.
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| Herpes simplex virus serological reagents.
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| Hepatitis A virus (HAV) serological assays.
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| Influenza virus serological reagents.
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| Reagents for detection of specific novel influenza A viruses.
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| spp. serological reagents.
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| spp. serological reagents.
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| spp. serological reagents.
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| Lymphocytic choriomeningitis virus serological reagents.
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| immunofluorescent reagents.
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| spp. serological reagents.
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| Mumps virus serological reagents.
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| spp. direct serological test reagents.
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| Parainfluenza virus serological reagents.
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| Poliovirus serological reagents.
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| spp. (Weil-Felix) serological reagents.
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| spp. serological reagents.
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| Rabiesvirus immunofluorescent reagents.
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| Reovirus serological reagents.
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| Respiratory syncytial virus serological reagents.
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| Rhinovirus serological reagents.
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| Rickettsia serological reagents.
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| Rubella virus serological reagents.
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| Rubeola (measles) virus serological reagents.
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| spp. serological reagents.
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| spp. serological reagents.
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| spp. serological reagents.
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| spp. serological reagents.
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| spp. serological reagents.
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| nontreponemal test reagents.
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| treponemal test reagents.
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| spp. serological reagents.
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| Varicella-zoster virus serological reagents.
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| West Nile virus serological reagents.
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Subpart E--IMMUNOLOGY LABORATORY EQUIPMENT AND REAGENTS
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| RNA Preanalytical Systems.
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| Immunoelectrophoresis equipment.
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| Immunofluorometer equipment.
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| Immunonephelometer equipment.
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| Automated fluorescence hybridization (FISH) enumeration systems.
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| Radial immunodiffusion plate.
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| Rocket immunoelectrophoresis equipment.
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Subpart F--IMMUNOLOGICAL TEST SYSTEMS
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| Albumin immunological test system.
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| Prealbumin immunological test system.
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| Human allotypic marker immunological test system.
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| -1-antichymotrypsin immunological test system.
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| Antimitochondrial antibody immunological test system.
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| Antinuclear antibody immunological test system.
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| Antiparietal antibody immunological test system.
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| Antismooth muscle antibody immunological test system.
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| -1-antitrypsin immunological test system.
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| Bence-Jones proteins immunological test system.
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| -globulin immunological test system.
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| Breast milk immunological test system.
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| Carbonic anhydrase B and C immunological test system.
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| Ceruloplasmin immunological test system.
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| Cohn fraction II immunological test system.
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| Colostrum immunological test system.
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| Complement components immunological test system.
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| Complement C2 inhibitor (inactivator) immunological test system.
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| Complement C inactivator immunological test system.
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| C-reactive protein immunological test system.
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| Properdin factor B immunological test system.
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| Factor XIII, A, S, immunological test system.
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| Ferritin immunological test system.
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| Fibrinopeptide A immunological test system.
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| Cohn fraction IV immunological test system.
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| Cohn fraction V immunological test system.
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| Free secretory component immunological test system.
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| -globulin immunological test system.
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| -1-glycoproteins immunological test system.
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| -2-glycoproteins immunological test system.
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| -2-glycoprotein I immunological test system.
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| -2-glycoprotein III immunological test system.
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| Haptoglobin immunological test system.
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| Hemoglobin immunological test system.
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| Hemopexin immunological test system.
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| Hypersensitivity pneumonitis immunological test system.
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| Immunoglobulins A, G, M, D, and E immunological test system.
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| Immunoglobulin G (Fab fragment specific) immunological test system.
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| Immunoglobulin G (Fc fragment specific) immunological test system.
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| Immunoglobulin G (Fd fragment specific) immunological test system.
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| Immunoglobulin (light chain specific) immunological test system.
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| Lactic dehydrogenase immunological test system.
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| Lactoferrin immunological test system.
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| -1-lipoprotein immunological test system.
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| Lipoprotein X immunological test system.
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| Low-density lipoprotein immunological test system.
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| -2-macroglobulin immunological test system.
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| -2-microglobulin immunological test system.
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| Infectious mononucleosis immunological test system.
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| Multiple autoantibodies immunological test system.
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| Myoglobin immunological test system.
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| Whole human plasma or serum immunological test system.
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| Plasminogen immunological test system.
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| Prothrombin immunological test system.
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| Radioallergosorbent (RAST) immunological test system.
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| Retinol-binding protein immunological test system.
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| Rheumatoid factor immunological test system.
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| Anti- () antibody (ASCA) test systems.
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| Seminal fluid (sperm) immunological test system.
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| Systemic lupus erythematosus immunological test system.
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| Total spinal fluid immunological test system.
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| Thyroid autoantibody immunological test system.
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| Transferrin immunological test system.
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| Inter- trypsin inhibitor immunological test system.
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| Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
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Subpart G--TUMOR ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEMS
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| Tumor-associated antigen immunological test system.
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| Immunomagnetic circulating cancer cell selection and enumeration system.
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| AFP-L3% immunological test system.
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