Title 21

PART 866 SUBPART D

Subpart D - Serological Reagents

21:8.0.1.1.20.4.1.1SECTION 866.3010
   866.3010 Acinetobacter calcoaceticus serological reagents.
21:8.0.1.1.20.4.1.2SECTION 866.3020
   866.3020 Adenovirus serological reagents.
21:8.0.1.1.20.4.1.3SECTION 866.3035
   866.3035 Arizona spp. serological reagents.
21:8.0.1.1.20.4.1.4SECTION 866.3040
   866.3040 Aspergillus spp. serological reagents.
21:8.0.1.1.20.4.1.5SECTION 866.3045
   866.3045 In vitro diagnostic device for Bacillus spp. detection.
21:8.0.1.1.20.4.1.6SECTION 866.3050
   866.3050 Beta-glucan serological assays.
21:8.0.1.1.20.4.1.7SECTION 866.3060
   866.3060 Blastomyces dermatitidis serological reagents.
21:8.0.1.1.20.4.1.8SECTION 866.3065
   866.3065 Bordetella spp. serological reagents.
21:8.0.1.1.20.4.1.9SECTION 866.3085
   866.3085 Brucella spp. serological reagents.
21:8.0.1.1.20.4.1.10SECTION 866.3110
   866.3110 Campylobacter fetus serological reagents.
21:8.0.1.1.20.4.1.11SECTION 866.3120
   866.3120 Chlamydia serological reagents.
21:8.0.1.1.20.4.1.12SECTION 866.3125
   866.3125 Citrobacter spp. serological reagents.
21:8.0.1.1.20.4.1.13SECTION 866.3130
   866.3130 Clostridium difficile toxin gene amplification assay.
21:8.0.1.1.20.4.1.14SECTION 866.3135
   866.3135 Coccidioides immitis serological reagents.
21:8.0.1.1.20.4.1.15SECTION 866.3140
   866.3140 Corynebacterium spp. serological reagents.
21:8.0.1.1.20.4.1.16SECTION 866.3145
   866.3145 Coxsackievirus serological reagents.
21:8.0.1.1.20.4.1.17SECTION 866.3165
   866.3165 Cryptococcus neoformans serological reagents.
21:8.0.1.1.20.4.1.18SECTION 866.3175
   866.3175 Cytomegalovirus serological reagents.
21:8.0.1.1.20.4.1.19SECTION 866.3200
   866.3200 Echinococcus spp. serological reagents.
21:8.0.1.1.20.4.1.20SECTION 866.3205
   866.3205 Echovirus serological reagents.
21:8.0.1.1.20.4.1.21SECTION 866.3210
   866.3210 Endotoxin assay.
21:8.0.1.1.20.4.1.22SECTION 866.3215
   866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
21:8.0.1.1.20.4.1.23SECTION 866.3220
   866.3220 Entamoeba histolytica serological reagents.
21:8.0.1.1.20.4.1.24SECTION 866.3225
   866.3225 Enterovirus nucleic acid assay.
21:8.0.1.1.20.4.1.25SECTION 866.3235
   866.3235 Epstein-Barr virus serological reagents.
21:8.0.1.1.20.4.1.26SECTION 866.3240
   866.3240 Equine encephalomyelitis virus serological reagents.
21:8.0.1.1.20.4.1.27SECTION 866.3250
   866.3250 Erysipelothrix rhusiopathiae serological reagents.
21:8.0.1.1.20.4.1.28SECTION 866.3255
   866.3255 Escherichia coli serological reagents.
21:8.0.1.1.20.4.1.29SECTION 866.3270
   866.3270 Flavobacterium spp. serological reagents.
21:8.0.1.1.20.4.1.30SECTION 866.3280
   866.3280 Francisella tularensis serological reagents.
21:8.0.1.1.20.4.1.31SECTION 866.3290
   866.3290 Gonococcal antibody test (GAT).
21:8.0.1.1.20.4.1.32SECTION 866.3300
   866.3300 Haemophilus spp. serological reagents.
21:8.0.1.1.20.4.1.33SECTION 866.3305
   866.3305 Herpes simplex virus serological assays.
21:8.0.1.1.20.4.1.34SECTION 866.3309
   866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
21:8.0.1.1.20.4.1.35SECTION 866.3310
   866.3310 Hepatitis A virus (HAV) serological assays.
21:8.0.1.1.20.4.1.36SECTION 866.3320
   866.3320 Histoplasma capsulatum serological reagents.
21:8.0.1.1.20.4.1.37SECTION 866.3328
   866.3328 Influenza virus antigen detection test system.
21:8.0.1.1.20.4.1.38SECTION 866.3330
   866.3330 Influenza virus serological reagents.
21:8.0.1.1.20.4.1.39SECTION 866.3332
   866.3332 Reagents for detection of specific novel influenza A viruses.
21:8.0.1.1.20.4.1.40SECTION 866.3336
   866.3336 John Cunningham Virus serological reagents.
21:8.0.1.1.20.4.1.41SECTION 866.3340
   866.3340 Klebsiella spp. serological reagents.
21:8.0.1.1.20.4.1.42SECTION 866.3350
   866.3350 Leptospira spp. serological reagents.
21:8.0.1.1.20.4.1.43SECTION 866.3355
   866.3355 Listeria spp. serological reagents.
21:8.0.1.1.20.4.1.44SECTION 866.3360
   866.3360 Lymphocytic choriomeningitis virus serological reagents.
21:8.0.1.1.20.4.1.45SECTION 866.3361
   866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.
21:8.0.1.1.20.4.1.46SECTION 866.3365
   866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
21:8.0.1.1.20.4.1.47SECTION 866.3370
   866.3370 Mycobacterium tuberculosis immunofluorescent reagents.
21:8.0.1.1.20.4.1.48SECTION 866.3372
   866.3372 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
21:8.0.1.1.20.4.1.49SECTION 866.3373
   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.
21:8.0.1.1.20.4.1.50SECTION 866.3375
   866.3375 Mycoplasma spp. serological reagents.
21:8.0.1.1.20.4.1.51SECTION 866.3380
   866.3380 Mumps virus serological reagents.
21:8.0.1.1.20.4.1.52SECTION 866.3390
   866.3390 Neisseria spp. direct serological test reagents.
21:8.0.1.1.20.4.1.53SECTION 866.3395
   866.3395 Norovirus serological reagents.
21:8.0.1.1.20.4.1.54SECTION 866.3400
   866.3400 Parainfluenza virus serological reagents.
21:8.0.1.1.20.4.1.55SECTION 866.3402
   866.3402 Plasmodium species antigen detection assays.
21:8.0.1.1.20.4.1.56SECTION 866.3405
   866.3405 Poliovirus serological reagents.
21:8.0.1.1.20.4.1.57SECTION 866.3410
   866.3410 Proteus spp. (Weil-Felix) serological reagents.
21:8.0.1.1.20.4.1.58SECTION 866.3415
   866.3415 Pseudomonas spp. serological reagents.
21:8.0.1.1.20.4.1.59SECTION 866.3460
   866.3460 Rabiesvirus immunofluorescent reagents.
21:8.0.1.1.20.4.1.60SECTION 866.3470
   866.3470 Reovirus serological reagents.
21:8.0.1.1.20.4.1.61SECTION 866.3480
   866.3480 Respiratory syncytial virus serological reagents.
21:8.0.1.1.20.4.1.62SECTION 866.3490
   866.3490 Rhinovirus serological reagents.
21:8.0.1.1.20.4.1.63SECTION 866.3500
   866.3500 Rickettsia serological reagents.
21:8.0.1.1.20.4.1.64SECTION 866.3510
   866.3510 Rubella virus serological reagents.
21:8.0.1.1.20.4.1.65SECTION 866.3520
   866.3520 Rubeola (measles) virus serological reagents.
21:8.0.1.1.20.4.1.66SECTION 866.3550
   866.3550 Salmonella spp. serological reagents.
21:8.0.1.1.20.4.1.67SECTION 866.3600
   866.3600 Schistosoma spp. serological reagents.
21:8.0.1.1.20.4.1.68SECTION 866.3630
   866.3630 Serratia spp. serological reagents.
21:8.0.1.1.20.4.1.69SECTION 866.3660
   866.3660 Shigella spp. serological reagents.
21:8.0.1.1.20.4.1.70SECTION 866.3680
   866.3680 Sporothrix schenckii serological reagents.
21:8.0.1.1.20.4.1.71SECTION 866.3700
   866.3700 Staphylococcus aureus serological reagents.
21:8.0.1.1.20.4.1.72SECTION 866.3720
   866.3720 Streptococcus spp. exoenzyme reagents.
21:8.0.1.1.20.4.1.73SECTION 866.3740
   866.3740 Streptococcus spp. serological reagents.
21:8.0.1.1.20.4.1.74SECTION 866.3780
   866.3780 Toxoplasma gondii serological reagents.
21:8.0.1.1.20.4.1.75SECTION 866.3820
   866.3820 Treponema pallidum nontreponemal test reagents.
21:8.0.1.1.20.4.1.76SECTION 866.3830
   866.3830 Treponema pallidum treponemal test reagents.
21:8.0.1.1.20.4.1.77SECTION 866.3850
   866.3850 Trichinella spiralis serological reagents.
21:8.0.1.1.20.4.1.78SECTION 866.3860
   866.3860 Trichomonas vaginalis nucleic acid assay.
21:8.0.1.1.20.4.1.79SECTION 866.3870
   866.3870 Trypanosoma spp. serological reagents.
21:8.0.1.1.20.4.1.80SECTION 866.3900
   866.3900 Varicella-zoster virus serological reagents.
21:8.0.1.1.20.4.1.81SECTION 866.3920
   866.3920 Assayed quality control material for clinical microbiology assays.
21:8.0.1.1.20.4.1.82SECTION 866.3930
   866.3930 Vibrio cholerae serological reagents.
21:8.0.1.1.20.4.1.83SECTION 866.3940
   866.3940 West Nile virus serological reagents.
21:8.0.1.1.20.4.1.84SECTION 866.3945
   866.3945 Dengue virus serological reagents.
21:8.0.1.1.20.4.1.85SECTION 866.3946
   866.3946 Dengue virus nucleic acid amplification test reagents.
21:8.0.1.1.20.4.1.86SECTION 866.3950
   866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
21:8.0.1.1.20.4.1.87SECTION 866.3955
   866.3955 Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
21:8.0.1.1.20.4.1.88SECTION 866.3960
   866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
21:8.0.1.1.20.4.1.89SECTION 866.3970
   866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
21:8.0.1.1.20.4.1.90SECTION 866.3980
   866.3980 Respiratory viral panel multiplex nucleic acid assay.
21:8.0.1.1.20.4.1.91SECTION 866.3985
   866.3985 Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
21:8.0.1.1.20.4.1.92SECTION 866.3990
   866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.