21 CFR Subpart D
Serological Reagents
June 25, 2020
§
866.3035
Arizona spp. serological reagents
§
866.3010
Acinetobacter calcoaceticus serological reagents
§
866.3020
Adenovirus 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
§
866.3120
Chlamydia serological reagents
§
866.3125
Citrobacter spp. serological reagents
§
866.3130
Clostridium difficile toxin gene amplification assay
§
866.3135
Coccidioides immitis serological reagents
§
866.3490
Rhinovirus serological reagents
§
866.3140
Corynebacterium spp. serological reagents
§
866.3145
Coxsackievirus serological reagents
§
866.3165
Cryptococcus neoformans serological reagents
§
866.3175
Cytomegalovirus serological reagents
§
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
§
866.3240
Equine encephalomyelitis virus serological reagents
§
866.3250
Erysipelothrix rhusiopathiae serological reagents
§
866.3255
Escherichia coli serological reagents
§
866.3270
Flavobacterium spp. serological reagents
§
866.3500
Rickettsia 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
§
866.3830
Treponema pallidum treponemal test reagents
§
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
§
866.3940
West Nile 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
§
866.3510
Rubella virus 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
§
866.3520
Rubeola (measles) virus 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
§
866.3550
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
§
866.3850
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
§
866.3945
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
§
866.3960
Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens
§
866.3970
Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid
§
866.3980
Respiratory viral panel multiplex nucleic acid assay
§
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