Serological Reagents | Midpage

Collections
Code of Federal Regulations

Subpart D

Serological Reagents

866.301021 C.F.R. § 866.3010 866.3020Adenovirus serological reagents.866.303521 C.F.R. § 866.3035 866.304021 C.F.R. § 866.3040 866.3045In vitro diagnostic device for 866.3046Simple in vitro diagnostic device for the detection of secreted proteins from 866.3050Beta-glucan serological assays.866.306021 C.F.R. § 866.3060 866.306521 C.F.R. § 866.3065 866.308521 C.F.R. § 866.3085 866.311021 C.F.R. § 866.3110 866.3120Chlamydia serological reagents.866.312521 C.F.R. § 866.3125 866.3130Clostridium difficile toxin gene amplification assay.866.313521 C.F.R. § 866.3135 866.314021 C.F.R. § 866.3140 866.3145Coxsackievirus serological reagents.866.316521 C.F.R. § 866.3165 866.3169Hepatitis C virus antibody tests.866.3170Nucleic acid-based hepatitis C virus ribonucleic acid tests.866.3172Qualitative hepatitis B virus antigen assays.866.3173Hepatitis B virus antibody assays.866.3174Hepatitis B virus nucleic acid-based assays.866.3175Cytomegalovirus serological reagents.866.3180Quantitative cytomegalovirus nucleic acid tests for transplant patient management.866.3181Cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection.866.3183Quantitative viral nucleic acid test for transplant patient management.866.320021 C.F.R. § 866.3200 866.3205Echovirus serological reagents.866.3210Endotoxin assay.866.3215Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.866.322021 C.F.R. § 866.3220 866.3225Enterovirus nucleic acid assay.866.3230Device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections.866.3231Device to detect bacterial protease activity in chronic wound fluid.866.3235Epstein-Barr virus serological reagents.866.3236Device to detect or measure nucleic acid from viruses associated with head and neck cancers.866.3240Equine encephalomyelitis virus serological reagents.866.325021 C.F.R. § 866.3250 866.325521 C.F.R. § 866.3255 866.327021 C.F.R. § 866.3270 866.328021 C.F.R. § 866.3280 866.3290Gonococcal antibody test (GAT).866.330021 C.F.R. § 866.3300 866.3305Herpes simplex virus serological assays.866.3307Herpes simplex virus nucleic acid-based assay for central nervous system infections.866.3309Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.866.3310Hepatitis A virus (HAV) serological assays.866.332021 C.F.R. § 866.3320 866.3328Influenza virus antigen detection test system.866.3330Influenza virus serological reagents.866.3332Reagents for detection of specific novel influenza A viruses.866.3336John Cunningham Virus serological reagents.866.334021 C.F.R. § 866.3340 866.335021 C.F.R. § 866.3350 866.335521 C.F.R. § 866.3355 866.3360Lymphocytic choriomeningitis virus serological reagents.866.3361Mass spectrometer system for clinical use for the identification of microorganisms.866.3365Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.866.3367Device to detect and identify microbial nucleic acids by FISH in clinical specimens.866.337021 C.F.R. § 866.3370 866.3372Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.866.3373Nucleic 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.866.337521 C.F.R. § 866.3375 866.3376Device to detect and identify fungal nucleic acids directly in respiratory specimens.866.3378Clinical mass spectrometry microorganism identification and differentiation system.866.3380Mumps virus serological reagents.866.339021 C.F.R. § 866.3390 866.3393Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).866.3395Norovirus serological reagents.866.3400Parainfluenza virus serological reagents.866.3402Plasmodium species antigen detection assays.866.3405Poliovirus serological reagents.866.341021 C.F.R. § 866.3410 866.341521 C.F.R. § 866.3415 866.3460Rabiesvirus immunofluorescent reagents.866.3470Reovirus serological reagents.866.3480Respiratory syncytial virus serological reagents.866.3490Rhinovirus serological reagents.866.3500Rickettsia serological reagents.866.3510Rubella virus serological reagents.866.3520Rubeola (measles) virus serological reagents.866.355021 C.F.R. § 866.3550 866.360021 C.F.R. § 866.3600 866.363021 C.F.R. § 866.3630 866.366021 C.F.R. § 866.3660 866.368021 C.F.R. § 866.3680 866.370021 C.F.R. § 866.3700 866.372021 C.F.R. § 866.3720 866.374021 C.F.R. § 866.3740 866.378021 C.F.R. § 866.3780 866.382021 C.F.R. § 866.3820 866.383021 C.F.R. § 866.3830 866.385021 C.F.R. § 866.3850 866.386021 C.F.R. § 866.3860 866.387021 C.F.R. § 866.3870 866.3900Varicella-zoster virus serological reagents.866.3920Assayed quality control material for clinical microbiology assays.866.393021 C.F.R. § 866.3930 866.3935Zika virus serological reagents.866.3940West Nile virus serological reagents.866.3945Dengue virus serological reagents.866.3946Dengue virus nucleic acid amplification test reagents.866.3950In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.866.3955Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.866.3956Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.866.3957Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test.866.3958Human immunodeficiency virus (HIV) viral load monitoring test.866.3960Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.866.3966Device to detect and identify selected microbial agents that cause acute febrile illness.866.3970Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.866.3975Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis.866.3980Respiratory viral panel multiplex nucleic acid assay.866.3981Device 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.866.3982Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.866.3983SARS-CoV-2 serology test.866.3985Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.866.3988Device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection.866.3990Gastrointestinal microorganism multiplex nucleic acid-based assay.866.4001A multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens.