Part 866 — Immunology and Microbiology Devices
Subpart A — General Provisions
Subpart B — Diagnostic Devices
- § 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.
Subpart C — Microbiology Devices
- § 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.
Subpart D — Serological Reagents
- § 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.
- § 866.3050— 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.
- § 866.3985— Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
- § 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.
Subpart E — Immunology Laboratory Equipment and Reagents
- § 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.
Subpart F — Immunological Test Systems
- § 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.
- § 866.5860— 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.
Subpart G — Tumor Associated Antigen immunological Test Systems
- § 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.