Serological Reagents

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Immunology and Microbiology Devices
  7. Serological Reagents

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Section
866.3010

<em>Acinetobacter calcoaceticus</em> serological reagents.

Section
866.3020

Adenovirus serological reagents.

Section
866.3035

<em>Arizona</em> spp. serological reagents.

Section
866.3040

<em>Aspergillus</em> spp. serological reagents.

Section
866.3045

In vitro diagnostic device for <em>Bacillus</em> spp. detection.

Section
866.3050

Beta-glucan serological assays.

Section
866.3060

<em>Blastomyces dermatitidis</em> serological reagents.

Section
866.3065

<em>Bordetella</em> spp. serological reagents.

Section
866.3085

<em>Brucella</em> spp. serological reagents.

Section
866.3110

<em>Campylobacter fetus</em> serological reagents.

Section
866.3120

Chlamydia serological reagents.

Section
866.3125

<em>Citrobacter</em> spp. serological reagents.

Section
866.3130

Clostridium difficile toxin gene amplification assay.

Section
866.3135

<em>Coccidioides immitis</em> serological reagents.

Section
866.3140

<em>Corynebacterium</em> spp. serological reagents.

Section
866.3145

Coxsackievirus serological reagents.

Section
866.3165

<em>Cryptococcus neoformans</em> serological reagents.

Section
866.3169

Hepatitis C virus antibody tests.

Section
866.3170

Nucleic acid-based hepatitis C virus ribonucleic acid tests.

Section
866.3175

Cytomegalovirus serological reagents.

Section
866.3200

<em>Echinococcus</em> spp. serological reagents.

Section
866.3205

Echovirus serological reagents.

Section
866.3210

Endotoxin assay.

Section
866.3215

Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.

Section
866.3220

<em>Entamoeba histolytica</em> serological reagents.

Section
866.3225

Enterovirus nucleic acid assay.

Section
866.3235

Epstein-Barr virus serological reagents.

Section
866.3240

Equine encephalomyelitis virus serological reagents.

Section
866.3250

<em>Erysipelothrix rhusiopathiae</em> serological reagents.

Section
866.3255

<em>Escherichia coli</em> serological reagents.

Section
866.3270

<em>Flavobacterium</em> spp. serological reagents.

Section
866.3280

<em>Francisella tularensis</em> serological reagents.

Section
866.3290

Gonococcal antibody test (GAT).

Section
866.3300

<em>Haemophilus</em> spp. serological reagents.

Section
866.3305

Herpes simplex virus serological assays.

Section
866.3309

Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.

Section
866.3310

Hepatitis A virus (HAV) serological assays.

Section
866.3320

<em>Histoplasma capsulatum</em> serological reagents.

Section
866.3328

Influenza virus antigen detection test system.

Section
866.3330

Influenza virus serological reagents.

Section
866.3332

Reagents for detection of specific novel influenza A viruses.

Section
866.3336

John Cunningham Virus serological reagents.

Section
866.3340

<em>Klebsiella</em> spp. serological reagents.

Section
866.3350

<em>Leptospira</em> spp. serological reagents.

Section
866.3355

<em>Listeria</em> spp. serological reagents.

Section
866.3360

Lymphocytic choriomeningitis virus serological reagents.

Section
866.3361

Mass spectrometer system for clinical use for the identification of microorganisms.

Section
866.3365

Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

Section
866.3370

<em>Mycobacterium tuberculosis</em> immunofluorescent reagents.

Section
866.3372

Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.

Section
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.

Section
866.3375

<em>Mycoplasma</em> spp. serological reagents.

Section
866.3380

Mumps virus serological reagents.

Section
866.3390

<em>Neisseria</em> spp. direct serological test reagents.

Section
866.3395

Norovirus serological reagents.

Section
866.3400

Parainfluenza virus serological reagents.

Section
866.3402

Plasmodium species antigen detection assays.

Section
866.3405

Poliovirus serological reagents.

Section
866.3410

<em>Proteus</em> spp. (Weil-Felix) serological reagents.

Section
866.3415

<em>Pseudomonas</em> spp. serological reagents.

Section
866.3460

Rabiesvirus immunofluorescent reagents.

Section
866.3470

Reovirus serological reagents.

Section
866.3480

Respiratory syncytial virus serological reagents.

Section
866.3490

Rhinovirus serological reagents.

Section
866.3500

Rickettsia serological reagents.

Section
866.3510

Rubella virus serological reagents.

Section
866.3520

Rubeola (measles) virus serological reagents.

Section
866.3550

<em>Salmonella</em> spp. serological reagents.

Section
866.3600

<em>Schistosoma</em> spp. serological reagents.

Section
866.3630

<em>Serratia</em> spp. serological reagents.

Section
866.3660

<em>Shigella</em> spp. serological reagents.

Section
866.3680

<em>Sporothrix schenckii</em> serological reagents.

Section
866.3700

<em>Staphylococcus aureus</em> serological reagents.

Section
866.3720

<em>Streptococcus</em> spp. exoenzyme reagents.

Section
866.3740

<em>Streptococcus</em> spp. serological reagents.

Section
866.3780

<em>Toxoplasma gondii</em> serological reagents.

Section
866.3820

<em>Treponema pallidum</em> nontreponemal test reagents.

Section
866.3830

<em>Treponema pallidum</em> treponemal test reagents.

Section
866.3850

<em>Trichinella spiralis</em> serological reagents.

Section
866.3860

<em>Trichomonas vaginalis</em> nucleic acid assay.

Section
866.3870

<em>Trypanosoma</em> spp. serological reagents.

Section
866.3900

Varicella-zoster virus serological reagents.

Section
866.3920

Assayed quality control material for clinical microbiology assays.

Section
866.3930

<em>Vibrio cholerae</em> serological reagents.

Section
866.3940

West Nile virus serological reagents.

Section
866.3945

Dengue virus serological reagents.

Section
866.3946

Dengue virus nucleic acid amplification test reagents.

Section
866.3950

In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.

Section
866.3955

Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.

Section
866.3960

Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.

Section
866.3970

Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.

Section
866.3980

Respiratory viral panel multiplex nucleic acid assay.

Section
866.3985

Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.

Section
866.3990

Gastrointestinal microorganism multiplex nucleic acid-based assay.