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- 21 CFR 866.3940 · West Nile virus serological reagents.
- 21 CFR 866.3945 · Dengue virus serological reagents.
- 21 CFR 866.3946 · Dengue virus nucleic acid amplification test reagents.
- 21 CFR 866.3950 · In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
- 21 CFR 866.3955 · Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
- 21 CFR 866.3956 · Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.
- 21 CFR 866.3957 · Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test.
- 21 CFR 866.3958 · Human immunodeficiency virus (HIV) viral load monitoring test.
- 21 CFR 866.3960 · Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
- 21 CFR 866.3966 · Device to detect and identify selected microbial agents that cause acute febrile illness.
- 21 CFR 866.3970 · Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
- 21 CFR 866.3975 · Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis.
- 21 CFR 866.3980 · Respiratory viral panel multiplex nucleic acid assay.
- 21 CFR 866.3981 · Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.
- 21 CFR 866.3982 · Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.
- 21 CFR 866.3983 · SARS-CoV-2 serology test.
- 21 CFR 866.3984 · Over-the-counter test to detect SARS-CoV-2 from clinical specimens.
- 21 CFR 866.3985 · Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
- 21 CFR 866.3988 · Device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection.
- 21 CFR 866.3990 · Gastrointestinal microorganism multiplex nucleic acid-based assay.
- 21 CFR 866.4001 · A multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens.
- 21 CFR 866.4070 · RNA Preanalytical Systems.
- 21 CFR 866.4100 · Complement reagent.
- 21 CFR 866.4500 · Immunoelectrophoresis equipment.
- 21 CFR 866.4520 · Immunofluorometer equipment.
- 21 CFR 866.4540 · Immunonephelometer equipment.
- 21 CFR 866.4600 · Ouchterlony agar plate.
- 21 CFR 866.4700 · Automated fluorescence in situ hybridization (FISH) enumeration systems.
- 21 CFR 866.4750 · Automated indirect immunofluorescence microscope and software-assisted system.
- 21 CFR 866.4800 · Radial immunodiffusion plate.
- 21 CFR 866.4830 · Rocket immunoelectrophoresis equipment.
- 21 CFR 866.4900 · Support gel.
- 21 CFR 866.5040 · Albumin immunological test system.
- 21 CFR 866.5060 · Prealbumin immunological test system.
- 21 CFR 866.5065 · Human allotypic marker immunological test system.
- 21 CFR 866.5080 · Alpha-1-antichymotrypsin immunological test system.
- 21 CFR 866.5090 · Antimitochondrial antibody immunological test system.
- 21 CFR 866.5100 · Antinuclear antibody immunological test system.
- 21 CFR 866.5110 · Antiparietal antibody immunological test system.
- 21 CFR 866.5120 · Antismooth muscle antibody immunological test system.
- 21 CFR 866.5130 · Alpha-1-antitrypsin immunological test system.
- 21 CFR 866.5150 · Bence-Jones proteins immunological test system.
- 21 CFR 866.5160 · Beta-globulin immunological test system.
- 21 CFR 866.5170 · Breast milk immunological test system.
- 21 CFR 866.5180 · Fecal calprotectin immunological test system.
- 21 CFR 866.5200 · Carbonic anhydrase B and C immunological test system.
- 21 CFR 866.5210 · Ceruloplasmin immunological test system.
- 21 CFR 866.5220 · Cohn fraction II immunological test system.
- 21 CFR 866.5230 · Colostrum immunological test system.
- 21 CFR 866.5240 · Complement components immunological test system.
- 21 CFR 866.5250 · Complement C1 inhibitor (inactivator) immunological test system.
- 21 CFR 866.5260 · Complement C3b inactivator immunological test system.
- 21 CFR 866.5270 · C-reactive protein immunological test system.
- 21 CFR 866.5320 · Properdin factor B immunological test system.
- 21 CFR 866.5330 · Factor XIII, A, S, immunological test system.
- 21 CFR 866.5340 · Ferritin immunological test system.
- 21 CFR 866.5350 · Fibrinopeptide A immunological test system.
- 21 CFR 866.5360 · Cohn fraction IV immunological test system.
- 21 CFR 866.5370 · Cohn fraction V immunological test system.
- 21 CFR 866.5380 · Free secretory component immunological test system.
- 21 CFR 866.5400 · Alpha-globulin immunological test system.
- 21 CFR 866.5420 · Alpha-1-glycoproteins immunological test system.
- 21 CFR 866.5425 · Alpha-2-glycoproteins immunological test system.
- 21 CFR 866.5430 · Beta-2-glycoprotein I immunological test system.
- 21 CFR 866.5440 · Beta-2-glycoprotein III immunological test system.
- 21 CFR 866.5460 · Haptoglobin immunological test system.
- 21 CFR 866.5470 · Hemoglobin immunological test system.
- 21 CFR 866.5490 · Hemopexin immunological test system.
- 21 CFR 866.5500 · Hypersensitivity pneumonitis immunological test system.
- 21 CFR 866.5510 · Immunoglobulins A, G, M, D, and E immunological test system.
- 21 CFR 866.5520 · Immunoglobulin G (Fab fragment specific) immunological test system.
- 21 CFR 866.5530 · Immunoglobulin G (Fc fragment specific) immunological test system.
- 21 CFR 866.5540 · Immunoglobulin G (Fd fragment specific) immunological test system.
- 21 CFR 866.5550 · Immunoglobulin (light chain specific) immunological test system.
- 21 CFR 866.5560 · Lactic dehydrogenase immunological test system.
- 21 CFR 866.5570 · Lactoferrin immunological test system.
- 21 CFR 866.5580 · Alpha-1-lipoprotein immunological test system.
- 21 CFR 866.5590 · Lipoprotein X immunological test system.
- 21 CFR 866.5600 · Low-density lipoprotein immunological test system.
- 21 CFR 866.5620 · Alpha-2-macroglobulin immunological test system.
- 21 CFR 866.5630 · Beta-2-microglobulin immunological test system.
- 21 CFR 866.5640 · Infectious mononucleosis immunological test system.
- 21 CFR 866.5660 · Multiple autoantibodies immunological test system.
- 21 CFR 866.5665 · Aquaporin-4 autoantibody immunological test system.
- 21 CFR 866.5670 · Zinc transporter 8 autoantibody immunological test system.
- 21 CFR 866.5680 · Myoglobin immunological test system.
- 21 CFR 866.5700 · Whole human plasma or serum immunological test system.
- 21 CFR 866.5715 · Plasminogen immunological test system.
- 21 CFR 866.5735 · Prothrombin immunological test system.
- 21 CFR 866.5750 · Radioallergosorbent (RAST) immunological test system.
- 21 CFR 866.5760 · Tryptase test system.
- 21 CFR 866.5765 · Retinol-binding protein immunological test system.
- 21 CFR 866.5775 · Rheumatoid factor immunological test system.
- 21 CFR 866.5780 · Anti-phospholipase A2 receptor immunological test system.
- 21 CFR 866.5785 · Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
- 21 CFR 866.5800 · Seminal fluid (sperm) immunological test system.
- 21 CFR 866.5820 · Systemic lupus erythematosus immunological test system.
- 21 CFR 866.5830 · Brain trauma assessment test.
- 21 CFR 866.5840 · Alzheimer's disease pathology assessment test.
- 21 CFR 866.5860 · Total spinal fluid immunological test system.