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[A1]
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Electronic Code of Federal Regulations
| e-CFR data is current as of June 2, 2020
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) 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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| Automated image assessment system for microbial colonies on solid culture media. |
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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 Neisseria 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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| Streptococcus spp. nucleic acid-based assay. |
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| Microbiological specimen collection and transport device. |
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Subpart D—SEROLOGICAL REAGENTS
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| Acinetobacter calcoaceticus serological reagents. |
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| Adenovirus serological reagents. |
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| Arizona spp. serological reagents. |
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| Aspergillus spp. serological reagents. |
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| In vitro diagnostic device for Bacillus spp. detection. |
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| Beta-glucan serological assays. |
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| Blastomyces dermatitidis serological reagents. |
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| Bordetella spp. serological reagents. |
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| Brucella spp. serological reagents. |
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| Campylobacter fetus serological reagents. |
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| Chlamydia serological reagents. |
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| Citrobacter spp. serological reagents. |
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| Clostridium difficile toxin gene amplification assay. |
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| Coccidioides immitis serological reagents. |
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| Corynebacterium spp. serological reagents. |
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| Coxsackievirus serological reagents. |
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| Cryptococcus neoformans serological reagents. |
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| Cytomegalovirus serological reagents. |
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| Echinococcus spp. serological reagents. |
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| Echovirus serological reagents. |
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| Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis. |
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| Entamoeba histolytica serological reagents. |
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| Enterovirus nucleic acid assay. |
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| Epstein-Barr virus serological reagents. |
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| Equine encephalomyelitis virus serological reagents. |
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| Erysipelothrix rhusiopathiae serological reagents. |
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| Escherichia coli serological reagents. |
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| Flavobacterium spp. serological reagents. |
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| Francisella tularensis serological reagents. |
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| Gonococcal antibody test (GAT). |
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| Haemophilus spp. serological reagents. |
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| Herpes simplex virus serological assays. |
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| Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel. |
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| Hepatitis A virus (HAV) serological assays. |
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| Histoplasma capsulatum serological reagents. |
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| Influenza virus antigen detection test system. |
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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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| John Cunningham Virus serological reagents. |
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| Klebsiella spp. serological reagents. |
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| Leptospira spp. serological reagents. |
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| Listeria spp. serological reagents. |
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| Lymphocytic choriomeningitis virus serological reagents. |
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| Mass spectrometer system for clinical use for the identification of microorganisms. |
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| Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. |
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| Mycobacterium tuberculosis immunofluorescent reagents. |
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| Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens. |
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| 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. |
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| Mycoplasma spp. serological reagents. |
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| Mumps virus serological reagents. |
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| Neisseria spp. direct serological test reagents. |
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| Norovirus serological reagents. |
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| Parainfluenza virus serological reagents. |
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| Plasmodium species antigen detection assays. |
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| Poliovirus serological reagents. |
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| Proteus spp. (Weil-Felix) serological reagents. |
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| Pseudomonas 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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| Salmonella spp. serological reagents. |
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| Schistosoma spp. serological reagents. |
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| Serratia spp. serological reagents. |
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| Shigella spp. serological reagents. |
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| Sporothrix schenckii serological reagents. |
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| Staphylococcus aureus serological reagents. |
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| Streptococcus spp. exoenzyme reagents. |
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| Streptococcus spp. serological reagents. |
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| Toxoplasma gondii serological reagents. |
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| Treponema pallidum nontreponemal test reagents. |
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| Treponema pallidum treponemal test reagents. |
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| Trichinella spiralis serological reagents. |
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| Trichomonas vaginalis nucleic acid assay. |
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| Trypanosoma spp. serological reagents. |
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| Varicella-zoster virus serological reagents. |
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| Assayed quality control material for clinical microbiology assays. |
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| Vibrio cholerae serological reagents. |
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| West Nile virus serological reagents. |
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| Dengue virus serological reagents. |
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| Dengue virus nucleic acid amplification test reagents. |
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| In vitro human immunodeficiency virus (HIV) drug resistance genotype assay. |
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| Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology. |
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| Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens. |
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| Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid. |
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| Respiratory viral panel multiplex nucleic acid assay. |
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| Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens. |
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| Gastrointestinal microorganism multiplex nucleic acid-based assay. |
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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 in situ hybridization (FISH) enumeration systems. |
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| Automated indirect immunofluorescence microscope and software-assisted system. |
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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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| Alpha-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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| Alpha-1-antitrypsin immunological test system. |
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| Bence-Jones proteins immunological test system. |
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| Beta-globulin immunological test system. |
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| Breast milk immunological test system. |
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| Fecal calprotectin 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 C1 inhibitor (inactivator) immunological test system. |
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| Complement C3b 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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| Alpha-globulin immunological test system. |
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| Alpha-1-glycoproteins immunological test system. |
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| Alpha-2-glycoproteins immunological test system. |
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| Beta-2-glycoprotein I immunological test system. |
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| Beta-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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| Alpha-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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| Alpha-2-macroglobulin immunological test system. |
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| Beta-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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| Aquaporin-4 autoantibody immunological test system. |
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| Zinc transporter 8 autoantibody 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-Saccharomyces cerevisiae (S. cerevisiae) 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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| Brain trauma assessment test. |
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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-alpha trypsin inhibitor immunological test system. |
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| Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system. |
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| Quality control material for cystic fibrosis nucleic acid assays. |
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| Newborn screening test for severe combined immunodeficiency disorder (SCID). |
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| Autosomal recessive carrier screening gene mutation detection system. |
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| Genetic health risk assessment 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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| Gene expression profiling test system for breast cancer prognosis. |
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| Ovarian adnexal mass assessment score test system. |
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| BCR-ABL quantitation test. |
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| Next generation sequencing based tumor profiling test. |
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