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Title 21
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Part 866
FEDERAL · 21 CFR
Part 866 — Immunology and Microbiology Devices
261 sections · Title 21: Food and Drugs
§ 866.1
Scope.
§ 866.3
Effective dates of requirement for premarket approval.
§ 866.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 866.1620
Antimicrobial susceptibility test disc.
§ 866.1640
Antimicrobial susceptibility test powder.
§ 866.1645
Fully automated short-term incubation cycle antimicrobial susceptibility system.
§ 866.1650
A cellular analysis system for multiplexed antimicrobial susceptibility testing.
§ 866.1655
System for detection of microorganisms and antimicrobial resistance using reporter expression.
§ 866.1700
Culture medium for antimicrobial susceptibility tests.
§ 866.2050
Staphylococcal typing bacteriophage.
§ 866.2120
Anaerobic chamber.
§ 866.2160
Coagulase plasma.
§ 866.2170
Automated colony counter.
§ 866.2180
Manual colony counter.
§ 866.2190
Automated image assessment system for microbial colonies on solid culture media.
§ 866.2300
Multipurpose culture medium.
§ 866.2320
Differential culture medium.
§ 866.2330
Enriched culture medium.
§ 866.2350
Microbiological assay culture medium.
§ 866.2360
Selective culture medium.
§ 866.2390
Transport culture medium.
§ 866.2410
Culture medium for pathogenic <em>Neisseria</em> spp.
§ 866.2420
Oxidase screening test for gonorrhea.
§ 866.2440
Automated medium dispensing and stacking device.
§ 866.2450
Supplement for culture media.
§ 866.2480
Quality control kit for culture media.
§ 866.2500
Microtiter diluting and dispensing device.
§ 866.2540
Microbiological incubator.
§ 866.2560
Microbial growth monitor.
§ 866.2580
Gas-generating device.
§ 866.2600
Wood's fluorescent lamp.
§ 866.2660
Microorganism differentiation and identification device.
§ 866.2680
<em>Streptococcus spp.</em> nucleic acid-based assay.
§ 866.2850
Automated zone reader.
§ 866.2900
Microbiological specimen collection and transport device.
§ 866.2950
Microbial nucleic acid storage and stabilization device.
§ 866.2952
Device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples.
§ 866.3010
<em>Acinetobacter calcoaceticus</em> serological reagents.
§ 866.3020
Adenovirus serological reagents.
§ 866.3035
<em>Arizona</em> spp. serological reagents.
§ 866.3040
<em>Aspergillus</em> spp. serological reagents.
§ 866.3045
In vitro diagnostic device for <em>Bacillus</em> spp. detection.
§ 866.3046
Simple in vitro diagnostic device for the detection of secreted proteins from <em>Bacillus</em> species (spp.) in human clinical samples.
§ 866.3050
Beta-glucan serological assays.
§ 866.3060
<em>Blastomyces dermatitidis</em> serological reagents.
§ 866.3065
<em>Bordetella</em> spp. serological reagents.
§ 866.3085
<em>Brucella</em> spp. serological reagents.
§ 866.3110
<em>Campylobacter fetus</em> serological reagents.
§ 866.3120
Chlamydia serological reagents.
§ 866.3125
<em>Citrobacter</em> spp. serological reagents.
§ 866.3130
Clostridium difficile toxin gene amplification assay.
§ 866.3135
<em>Coccidioides immitis</em> serological reagents.
§ 866.3140
<em>Corynebacterium</em> spp. serological reagents.
§ 866.3145
Coxsackievirus serological reagents.
§ 866.3165
<em>Cryptococcus neoformans</em> serological reagents.
§ 866.3169
Hepatitis C virus antibody tests.
§ 866.3170
Nucleic acid-based hepatitis C virus ribonucleic acid tests.
§ 866.3172
Qualitative hepatitis B virus antigen assays.
§ 866.3173
Hepatitis B virus antibody assays.
§ 866.3174
Hepatitis B virus nucleic acid-based assays.
§ 866.3175
Cytomegalovirus serological reagents.
§ 866.3180
Quantitative cytomegalovirus nucleic acid tests for transplant patient management.
§ 866.3181
Cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection.
§ 866.3183
Quantitative viral nucleic acid test for transplant patient management.
§ 866.3200
<em>Echinococcus</em> spp. serological reagents.
§ 866.3205
Echovirus serological reagents.
§ 866.3210
Endotoxin assay.
§ 866.3215
Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
§ 866.3220
<em>Entamoeba histolytica</em> serological reagents.
§ 866.3225
Enterovirus nucleic acid assay.
§ 866.3230
Device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections.
§ 866.3231
Device to detect bacterial protease activity in chronic wound fluid.
§ 866.3235
Epstein-Barr virus serological reagents.
§ 866.3236
Device to detect or measure nucleic acid from viruses associated with head and neck cancers.
§ 866.3240
Equine encephalomyelitis virus serological reagents.
§ 866.3250
<em>Erysipelothrix rhusiopathiae</em> serological reagents.
§ 866.3255
<em>Escherichia coli</em> serological reagents.
§ 866.3270
<em>Flavobacterium</em> spp. serological reagents.
§ 866.3280
<em>Francisella tularensis</em> serological reagents.
§ 866.3290
Gonococcal antibody test (GAT).
§ 866.3300
<em>Haemophilus</em> spp. serological reagents.
§ 866.3305
Herpes simplex virus serological assays.
§ 866.3307
Herpes simplex virus nucleic acid-based assay for central nervous system infections.
§ 866.3309
Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
§ 866.3310
Hepatitis A virus (HAV) serological assays.
§ 866.3320
<em>Histoplasma capsulatum</em> serological reagents.
§ 866.3328
Influenza virus antigen detection test system.
§ 866.3330
Influenza virus serological reagents.
§ 866.3332
Reagents for detection of specific novel influenza A viruses.
§ 866.3336
John Cunningham Virus serological reagents.
§ 866.3340
<em>Klebsiella</em> spp. serological reagents.
§ 866.3350
<em>Leptospira</em> spp. serological reagents.
§ 866.3355
<em>Listeria</em> spp. serological reagents.
§ 866.3360
Lymphocytic choriomeningitis virus serological reagents.
§ 866.3361
Mass spectrometer system for clinical use for the identification of microorganisms.
§ 866.3365
Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
§ 866.3367
Device to detect and identify microbial nucleic acids by FISH in clinical specimens.
§ 866.3370
<em>Mycobacterium tuberculosis</em> immunofluorescent reagents.
§ 866.3372
Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
§ 866.3373
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.
§ 866.3375
<em>Mycoplasma</em> spp. serological reagents.
§ 866.3376
Device to detect and identify fungal nucleic acids directly in respiratory specimens.
§ 866.3378
Clinical mass spectrometry microorganism identification and differentiation system.
§ 866.3380
Mumps virus serological reagents.
§ 866.3390
<em>Neisseria</em> spp. direct serological test reagents.
§ 866.3393
Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).
§ 866.3395
Norovirus serological reagents.
§ 866.3400
Parainfluenza virus serological reagents.
§ 866.3402
Plasmodium species antigen detection assays.
§ 866.3405
Poliovirus serological reagents.
§ 866.3410
<em>Proteus</em> spp. (Weil-Felix) serological reagents.
§ 866.3415
<em>Pseudomonas</em> spp. serological reagents.
§ 866.3460
Rabiesvirus immunofluorescent reagents.
§ 866.3470
Reovirus serological reagents.
§ 866.3480
Respiratory syncytial virus serological reagents.
§ 866.3490
Rhinovirus serological reagents.
§ 866.3500
Rickettsia serological reagents.
§ 866.3510
Rubella virus serological reagents.
§ 866.3520
Rubeola (measles) virus serological reagents.
§ 866.3550
<em>Salmonella</em> spp. serological reagents.
§ 866.3600
<em>Schistosoma</em> spp. serological reagents.
§ 866.3630
<em>Serratia</em> spp. serological reagents.
§ 866.3660
<em>Shigella</em> spp. serological reagents.
§ 866.3680
<em>Sporothrix schenckii</em> serological reagents.
§ 866.3700
<em>Staphylococcus aureus</em> serological reagents.
§ 866.3720
<em>Streptococcus</em> spp. exoenzyme reagents.
§ 866.3740
<em>Streptococcus</em> spp. serological reagents.
§ 866.3780
<em>Toxoplasma gondii</em> serological reagents.
§ 866.3820
<em>Treponema pallidum</em> nontreponemal test reagents.
§ 866.3830
<em>Treponema pallidum</em> treponemal test reagents.
§ 866.3850
<em>Trichinella spiralis</em> serological reagents.
§ 866.3860
<em>Trichomonas vaginalis</em> nucleic acid assay.
§ 866.3870
<em>Trypanosoma</em> spp. serological reagents.
§ 866.3900
Varicella-zoster virus serological reagents.
§ 866.3920
Assayed quality control material for clinical microbiology assays.
§ 866.3930
<em>Vibrio cholerae</em> serological reagents.
§ 866.3935
Zika virus serological reagents.
§ 866.3940
West Nile virus serological reagents.
§ 866.3945
Dengue virus serological reagents.
§ 866.3946
Dengue virus nucleic acid amplification test reagents.
§ 866.3950
In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
§ 866.3955
Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
§ 866.3956
Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.
§ 866.3957
Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test.
§ 866.3958
Human immunodeficiency virus (HIV) viral load monitoring test.
§ 866.3960
Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
§ 866.3966
Device to detect and identify selected microbial agents that cause acute febrile illness.
§ 866.3970
Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
§ 866.3975
Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis.
§ 866.3980
Respiratory viral panel multiplex nucleic acid assay.
§ 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.
§ 866.3982
Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.
§ 866.3983
SARS-CoV-2 serology test.
§ 866.3984
Over-the-counter test to detect SARS-CoV-2 from clinical specimens.
§ 866.3985
Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
§ 866.3988
Device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection.
§ 866.3990
Gastrointestinal microorganism multiplex nucleic acid-based assay.
§ 866.4001
A multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens.
§ 866.4070
RNA Preanalytical Systems.
§ 866.4100
Complement reagent.
§ 866.4500
Immunoelectrophoresis equipment.
§ 866.4520
Immunofluorometer equipment.
§ 866.4540
Immunonephelometer equipment.
§ 866.4600
Ouchterlony agar plate.
§ 866.4700
Automated fluorescence <em>in situ</em> hybridization (FISH) enumeration systems.
§ 866.4750
Automated indirect immunofluorescence microscope and software-assisted system.
§ 866.4800
Radial immunodiffusion plate.
§ 866.4830
Rocket immunoelectrophoresis equipment.
§ 866.4900
Support gel.
§ 866.5040
Albumin immunological test system.
§ 866.5060
Prealbumin immunological test system.
§ 866.5065
Human allotypic marker immunological test system.
§ 866.5080
<em>Alpha</em>-1-antichymotrypsin immunological test system.
§ 866.5090
Antimitochondrial antibody immunological test system.
§ 866.5100
Antinuclear antibody immunological test system.
§ 866.5110
Antiparietal antibody immunological test system.
§ 866.5120
Antismooth muscle antibody immunological test system.
§ 866.5130
<em>Alpha</em>-1-antitrypsin immunological test system.
§ 866.5150
Bence-Jones proteins immunological test system.
§ 866.5160
<em>Beta</em>-globulin immunological test system.
§ 866.5170
Breast milk immunological test system.
§ 866.5180
Fecal calprotectin immunological test system.
§ 866.5200
Carbonic anhydrase B and C immunological test system.
§ 866.5210
Ceruloplasmin immunological test system.
§ 866.5220
Cohn fraction II immunological test system.
§ 866.5230
Colostrum immunological test system.
§ 866.5240
Complement components immunological test system.
§ 866.5250
Complement C<sub>1</sub> inhibitor (inactivator) immunological test system.
§ 866.5260
Complement C<sub>3b</sub> inactivator immunological test system.
§ 866.5270
C-reactive protein immunological test system.
§ 866.5320
Properdin factor B immunological test system.
§ 866.5330
Factor XIII, A, S, immunological test system.
§ 866.5340
Ferritin immunological test system.
§ 866.5350
Fibrinopeptide A immunological test system.
§ 866.5360
Cohn fraction IV immunological test system.
§ 866.5370
Cohn fraction V immunological test system.
§ 866.5380
Free secretory component immunological test system.
§ 866.5400
<em>Alpha</em>-globulin immunological test system.
§ 866.5420
<em>Alpha</em>-1-glycoproteins immunological test system.
§ 866.5425
<em>Alpha</em>-2-glycoproteins immunological test system.
§ 866.5430
<em>Beta</em>-2-glycoprotein I immunological test system.
§ 866.5440
<em>Beta</em>-2-glycoprotein III immunological test system.
§ 866.5460
Haptoglobin immunological test system.
§ 866.5470
Hemoglobin immunological test system.
§ 866.5490
Hemopexin immunological test system.
§ 866.5500
Hypersensitivity pneumonitis immunological test system.
§ 866.5510
Immunoglobulins A, G, M, D, and E immunological test system.
§ 866.5520
Immunoglobulin G (Fab fragment specific) immunological test system.
§ 866.5530
Immunoglobulin G (Fc fragment specific) immunological test system.
§ 866.5540
Immunoglobulin G (Fd fragment specific) immunological test system.
§ 866.5550
Immunoglobulin (light chain specific) immunological test system.
§ 866.5560
Lactic dehydrogenase immunological test system.
§ 866.5570
Lactoferrin immunological test system.
§ 866.5580
<em>Alpha</em>-1-lipoprotein immunological test system.
§ 866.5590
Lipoprotein X immunological test system.
§ 866.5600
Low-density lipoprotein immunological test system.
§ 866.5620
<em>Alpha</em>-2-macroglobulin immunological test system.
§ 866.5630
<em>Beta</em>-2-microglobulin immunological test system.
§ 866.5640
Infectious mononucleosis immunological test system.
§ 866.5660
Multiple autoantibodies immunological test system.
§ 866.5665
Aquaporin-4 autoantibody immunological test system.
§ 866.5670
Zinc transporter 8 autoantibody immunological test system.
§ 866.5680
Myoglobin immunological test system.
§ 866.5700
Whole human plasma or serum immunological test system.
§ 866.5715
Plasminogen immunological test system.
§ 866.5735
Prothrombin immunological test system.
§ 866.5750
Radioallergosorbent (RAST) immunological test system.
§ 866.5760
Tryptase test system.
§ 866.5765
Retinol-binding protein immunological test system.
§ 866.5775
Rheumatoid factor immunological test system.
§ 866.5780
Anti-phospholipase A2 receptor immunological test system.
§ 866.5785
Anti-<em>Saccharomyces cerevisiae</em> (<em>S. cerevisiae</em>) antibody (ASCA) test systems.
§ 866.5800
Seminal fluid (sperm) immunological test system.
§ 866.5820
Systemic lupus erythematosus immunological test system.
§ 866.5830
Brain trauma assessment test.
§ 866.5840
Alzheimer's disease pathology assessment test.
§ 866.5860
Total spinal fluid immunological test system.
§ 866.5870
Thyroid autoantibody immunological test system.
§ 866.5880
Transferrin immunological test system.
§ 866.5890
Inter-<em>alpha</em> trypsin inhibitor immunological test system.
§ 866.5900
Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
§ 866.5910
Quality control material for cystic fibrosis nucleic acid assays.
§ 866.5920
Postnatal chromosomal copy number variation detection system.
§ 866.5930
Newborn screening test for severe combined immunodeficiency disorder (SCID).
§ 866.5940
Autosomal recessive carrier screening gene mutation detection system.
§ 866.5950
Genetic health risk assessment system.
§ 866.5960
Human leukocyte antigen typing companion diagnostic test.
§ 866.5970
Inherited nucleotide repeat disorder DNA test.
§ 866.5980
Spinal Muscular Atrophy newborn screening test system.
§ 866.6000
Whole exome sequencing constituent device.
§ 866.6010
Tumor-associated antigen immunological test system.
§ 866.6020
Immunomagnetic circulating cancer cell selection and enumeration system.
§ 866.6030
AFP-L3% immunological test system.
§ 866.6040
Gene expression profiling test system for breast cancer prognosis.
§ 866.6050
Ovarian adnexal mass assessment score test system.
§ 866.6060
BCR-ABL quantitation test.
§ 866.6070
Mutation detection test for myeloproliferative neoplasms.
§ 866.6080
Next generation sequencing based tumor profiling test.
§ 866.6090
Cancer predisposition risk assessment system.
§ 866.6100
DNA-based test to measure minimal residual disease in hematological malignancies.
§ 866.6110
Circulating tumor cell enrichment device.