Subpart D. Subpart D—Serological Reagents

• § 866.3010 - Acinetobacter calcoaceticus serological reagents.
• § 866.3020 - Adenovirus serological reagents.
• § 866.3035 - Arizona spp. serological reagents.
• § 866.3040 - Aspergillus spp. serological reagents.
• § 866.3045 - In vitro diagnostic device for Bacillus spp. detection.
• § 866.3050 - Beta-glucan serological assays.
• § 866.3060 - Blastomyces dermatitidis serological reagents.
• § 866.3065 - Bordetella spp. serological reagents.
• § 866.3085 - Brucella spp. serological reagents.
• § 866.3110 - Campylobacter fetus serological reagents.
• § 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.
• § 866.3120 - Chlamydia serological reagents.
• § 866.3125 - Citrobacter spp. serological reagents.
• § 866.3130 - Clostridium difficile toxin gene amplification assay.
• § 866.3135 - Coccidioides immitis serological reagents.
• § 866.3140 - Corynebacterium spp. serological reagents.
• § 866.3145 - Coxsackievirus serological reagents.
• § 866.3165 - Cryptococcus neoformans serological reagents.
• § 866.3169 - Hepatitis C virus antibody tests.
• § 866.3170 - Nucleic acid-based hepatitis C virus ribonucleic acid tests.
• § 866.3175 - Cytomegalovirus serological reagents.
• § 866.3180 - Quantitative cytomegalovirus nucleic acid tests for transplant patient management.
• § 866.3183 - Quantitative viral nucleic acid test for transplant patient management.
• § 866.3200 - Echinococcus 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 - Entamoeba histolytica serological reagents.
• § 866.3225 - Enterovirus nucleic acid assay.
• § 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 - Erysipelothrix rhusiopathiae serological reagents.
• § 866.3255 - Escherichia coli serological reagents.
• § 866.3270 - Flavobacterium spp. serological reagents.
• § 866.3280 - Francisella tularensis serological reagents.
• § 866.3290 - Gonococcal antibody test (GAT).
• § 866.3300 - Haemophilus spp. serological reagents.
• § 866.3305 - Herpes simplex virus serological assays.
• § 866.3309 - Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
• § 866.3310 - Hepatitis A virus (HAV) serological assays.
• § 866.3320 - Histoplasma capsulatum 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 - Klebsiella spp. serological reagents.
• § 866.3350 - Leptospira spp. serological reagents.
• § 866.3355 - Listeria 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.
• § 866.3370 - Mycobacterium tuberculosis 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 - Mycoplasma spp. serological reagents.
• § 866.3380 - Mumps virus serological reagents.
• § 866.3390 - Neisseria spp. direct serological test reagents.
• § 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 - Proteus spp. (Weil-Felix) serological reagents.
• § 866.3415 - Pseudomonas 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 - Salmonella spp. serological reagents.
• § 866.3600 - Schistosoma spp. serological reagents.
• § 866.3630 - Serratia spp. serological reagents.
• § 866.3660 - Shigella spp. serological reagents.
• § 866.3680 - Sporothrix schenckii serological reagents.
• § 866.3700 - Staphylococcus aureus serological reagents.
• § 866.3720 - Streptococcus spp. exoenzyme reagents.
• § 866.3740 - Streptococcus spp. serological reagents.
• § 866.3780 - Toxoplasma gondii serological reagents.
• § 866.3820 - Treponema pallidum nontreponemal test reagents.
• § 866.3830 - Treponema pallidum treponemal test reagents.
• § 866.3850 - Trichinella spiralis serological reagents.
• § 866.3860 - Trichomonas vaginalis nucleic acid assay.
• § 866.3870 - Trypanosoma spp. serological reagents.
• § 866.3900 - Varicella-zoster virus serological reagents.
• § 866.3920 - Assayed quality control material for clinical microbiology assays.
• § 866.3930 - Vibrio cholerae 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.
• § 866.3980 - Respiratory viral panel multiplex nucleic acid assay.