Subpart D—Serological Reagents

1. CFR
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3. Title 21
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5. Chapter I
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7. Part 866
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9. Subpart D

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 866.3010
  § 866.3010 <em>Acinetobacter calcoaceticus</em> serological reagents.
• 866.3020
  § 866.3020 Adenovirus serological reagents.
• 866.3035
  § 866.3035 <em>Arizona</em> spp. serological reagents.
• 866.3040
  § 866.3040 <em>Aspergillus</em> spp. serological reagents.
• 866.3045
  § 866.3045 In vitro diagnostic device for <em>Bacillus</em> spp. detection.
• 866.3050
  § 866.3050 Beta-glucan serological assays.
• 866.3060
  § 866.3060 <em>Blastomyces dermatitidis</em> serological reagents.
• 866.3065
  § 866.3065 <em>Bordetella</em> spp. serological reagents.
• 866.3085
  § 866.3085 <em>Brucella</em> spp. serological reagents.
• 866.3110
  § 866.3110 <em>Campylobacter fetus</em> serological reagents.
• 866.3120
  § 866.3120 Chlamydia serological reagents.
• 866.3125
  § 866.3125 <em>Citrobacter</em> spp. serological reagents.
• 866.3130
  § 866.3130 Clostridium difficile toxin gene amplification assay.
• 866.3135
  § 866.3135 <em>Coccidioides immitis</em> serological reagents.
• 866.3140
  § 866.3140 <em>Corynebacterium</em> spp. serological reagents.
• 866.3145
  § 866.3145 Coxsackievirus serological reagents.
• 866.3165
  § 866.3165 <em>Cryptococcus neoformans</em> serological reagents.
• 866.3169
  § 866.3169 Hepatitis C virus antibody tests.
• 866.3170
  § 866.3170 Nucleic acid-based hepatitis C virus ribonucleic acid tests.
• 866.3172
  § 866.3172 Qualitative hepatitis B virus antigen assays.
• 866.3173
  § 866.3173 Hepatitis B virus antibody assays.
• 866.3174
  § 866.3174 Hepatitis B virus nucleic acid-based assays.
• 866.3175
  § 866.3175 Cytomegalovirus serological reagents.
• 866.3180
  § 866.3180 Quantitative cytomegalovirus nucleic acid tests for transplant patient management.
• 866.3181
  § 866.3181 Cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection.
• 866.3183
  § 866.3183 Quantitative viral nucleic acid test for transplant patient management.
• 866.3200
  § 866.3200 <em>Echinococcus</em> spp. serological reagents.
• 866.3205
  § 866.3205 Echovirus serological reagents.
• 866.3210
  § 866.3210 Endotoxin assay.
• 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.
• 866.3220
  § 866.3220 <em>Entamoeba histolytica</em> serological reagents.
• 866.3225
  § 866.3225 Enterovirus nucleic acid assay.
• 866.3230
  § 866.3230 Device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections.
• 866.3231
  § 866.3231 Device to detect bacterial protease activity in chronic wound fluid.
• 866.3235
  § 866.3235 Epstein-Barr virus serological reagents.
• 866.3236
  § 866.3236 Device to detect or measure nucleic acid from viruses associated with head and neck cancers.
• 866.3240
  § 866.3240 Equine encephalomyelitis virus serological reagents.
• 866.3250
  § 866.3250 <em>Erysipelothrix rhusiopathiae</em> serological reagents.
• 866.3255
  § 866.3255 <em>Escherichia coli</em> serological reagents.
• 866.3270
  § 866.3270 <em>Flavobacterium</em> spp. serological reagents.
• 866.3280
  § 866.3280 <em>Francisella tularensis</em> serological reagents.
• 866.3290
  § 866.3290 Gonococcal antibody test (GAT).
• 866.3300
  § 866.3300 <em>Haemophilus</em> spp. serological reagents.
• 866.3305
  § 866.3305 Herpes simplex virus serological assays.
• 866.3307
  § 866.3307 Herpes simplex virus nucleic acid-based assay for central nervous system infections.
• 866.3309
  § 866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
• 866.3310
  § 866.3310 Hepatitis A virus (HAV) serological assays.
• 866.3320
  § 866.3320 <em>Histoplasma capsulatum</em> serological reagents.
• 866.3328
  § 866.3328 Influenza virus antigen detection test system.
• 866.3330
  § 866.3330 Influenza virus serological reagents.
• 866.3332
  § 866.3332 Reagents for detection of specific novel influenza A viruses.
• 866.3336
  § 866.3336 John Cunningham Virus serological reagents.
• 866.3340
  § 866.3340 <em>Klebsiella</em> spp. serological reagents.
• 866.3350
  § 866.3350 <em>Leptospira</em> spp. serological reagents.
• 866.3355
  § 866.3355 <em>Listeria</em> spp. serological reagents.
• 866.3360
  § 866.3360 Lymphocytic choriomeningitis virus serological reagents.
• 866.3361
  § 866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.
• 866.3365
  § 866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
• 866.3367
  § 866.3367 Device to detect and identify microbial nucleic acids by FISH in clinical specimens.
• 866.3370
  § 866.3370 <em>Mycobacterium tuberculosis</em> immunofluorescent reagents.
• 866.3372
  § 866.3372 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
• 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.
• 866.3375
  § 866.3375 <em>Mycoplasma</em> spp. serological reagents.
• 866.3376
  § 866.3376 Device to detect and identify fungal nucleic acids directly in respiratory specimens.
• 866.3378
  § 866.3378 Clinical mass spectrometry microorganism identification and differentiation system.
• 866.3380
  § 866.3380 Mumps virus serological reagents.
• 866.3390
  § 866.3390 <em>Neisseria</em> spp. direct serological test reagents.
• 866.3393
  § 866.3393 Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).
• 866.3395
  § 866.3395 Norovirus serological reagents.
• 866.3400
  § 866.3400 Parainfluenza virus serological reagents.
• 866.3402
  § 866.3402 Plasmodium species antigen detection assays.
• 866.3405
  § 866.3405 Poliovirus serological reagents.
• 866.3410
  § 866.3410 <em>Proteus</em> spp. (Weil-Felix) serological reagents.
• 866.3415
  § 866.3415 <em>Pseudomonas</em> spp. serological reagents.
• 866.3460
  § 866.3460 Rabiesvirus immunofluorescent reagents.
• 866.3470
  § 866.3470 Reovirus serological reagents.
• 866.3480
  § 866.3480 Respiratory syncytial virus serological reagents.
• 866.3490
  § 866.3490 Rhinovirus serological reagents.
• 866.3500
  § 866.3500 Rickettsia serological reagents.
• 866.3510
  § 866.3510 Rubella virus serological reagents.
• 866.3520
  § 866.3520 Rubeola (measles) virus serological reagents.
• 866.3550
  § 866.3550 <em>Salmonella</em> spp. serological reagents.
• 866.3600
  § 866.3600 <em>Schistosoma</em> spp. serological reagents.
• 866.3630
  § 866.3630 <em>Serratia</em> spp. serological reagents.
• 866.3660
  § 866.3660 <em>Shigella</em> spp. serological reagents.
• 866.3680
  § 866.3680 <em>Sporothrix schenckii</em> serological reagents.
• 866.3700
  § 866.3700 <em>Staphylococcus aureus</em> serological reagents.
• 866.3720
  § 866.3720 <em>Streptococcus</em> spp. exoenzyme reagents.
• 866.3740
  § 866.3740 <em>Streptococcus</em> spp. serological reagents.
• 866.3780
  § 866.3780 <em>Toxoplasma gondii</em> serological reagents.
• 866.3820
  § 866.3820 <em>Treponema pallidum</em> nontreponemal test reagents.
• 866.3830
  § 866.3830 <em>Treponema pallidum</em> treponemal test reagents.
• 866.3850
  § 866.3850 <em>Trichinella spiralis</em> serological reagents.
• 866.3860
  § 866.3860 <em>Trichomonas vaginalis</em> nucleic acid assay.
• 866.3870
  § 866.3870 <em>Trypanosoma</em> spp. serological reagents.
• 866.3900
  § 866.3900 Varicella-zoster virus serological reagents.
• 866.3920
  § 866.3920 Assayed quality control material for clinical microbiology assays.
• 866.3930
  § 866.3930 <em>Vibrio cholerae</em> serological reagents.
• 866.3935
  § 866.3935 Zika virus serological reagents.
• 866.3940
  § 866.3940 West Nile virus serological reagents.
• 866.3945
  § 866.3945 Dengue virus serological reagents.
• 866.3946
  § 866.3946 Dengue virus nucleic acid amplification test reagents.
• 866.3950
  § 866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
• 866.3955
  § 866.3955 Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
• 866.3956
  § 866.3956 Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.
• 866.3957
  § 866.3957 Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test.
• 866.3958
  § 866.3958 Human immunodeficiency virus (HIV) viral load monitoring test.
• 866.3960
  § 866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
• 866.3966
  § 866.3966 Device to detect and identify selected microbial agents that cause acute febrile illness.
• 866.3970
  § 866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
• 866.3975
  § 866.3975 Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis.
• 866.3980
  § 866.3980 Respiratory viral panel multiplex nucleic acid assay.
• 866.3981
  § 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
  § 866.3985 Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
• 866.3990
  § 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
• 866.4001
  § 866.4001 A multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens.