Code of Federal Regulations · Subpart
Subpart D — Serological Reagents
21 C.F.R. pt. 866, subpt. D
- § 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
- § 866.3120 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
- § 866.3172 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 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
- § 866.3230 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 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
- § 866.3307 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 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
- § 866.3367 Device To Detect And Identify Microbial Nucleic Acids By Fish In Clinical Specimens
- § 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
- § 866.3376 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 Neisseria 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 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
- § 866.3935 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