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- 21 CFR 866.3010 · Acinetobacter calcoaceticus serological reagents.
- 21 CFR 866.3020 · Adenovirus serological reagents.
- 21 CFR 866.3035 · Arizona spp. serological reagents.
- 21 CFR 866.3040 · Aspergillus spp. serological reagents.
- 21 CFR 866.3045 · In vitro diagnostic device for Bacillus spp. detection.
- 21 CFR 866.3046 · Simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples.
- 21 CFR 866.3050 · Beta-glucan serological assays.
- 21 CFR 866.3060 · Blastomyces dermatitidis serological reagents.
- 21 CFR 866.3065 · Bordetella spp. serological reagents.
- 21 CFR 866.3085 · Brucella spp. serological reagents.
- 21 CFR 866.3110 · Campylobacter fetus serological reagents.
- 21 CFR 866.3120 · Chlamydia serological reagents.
- 21 CFR 866.3125 · Citrobacter spp. serological reagents.
- 21 CFR 866.3130 · Clostridium difficile toxin gene amplification assay.
- 21 CFR 866.3135 · Coccidioides immitis serological reagents.
- 21 CFR 866.3140 · Corynebacterium spp. serological reagents.
- 21 CFR 866.3145 · Coxsackievirus serological reagents.
- 21 CFR 866.3165 · Cryptococcus neoformans serological reagents.
- 21 CFR 866.3169 · Hepatitis C virus antibody tests.
- 21 CFR 866.3170 · Nucleic acid-based hepatitis C virus ribonucleic acid tests.
- 21 CFR 866.3172 · Qualitative hepatitis B virus antigen assays.
- 21 CFR 866.3173 · Hepatitis B virus antibody assays.
- 21 CFR 866.3174 · Hepatitis B virus nucleic acid-based assays.
- 21 CFR 866.3175 · Cytomegalovirus serological reagents.
- 21 CFR 866.3180 · Quantitative cytomegalovirus nucleic acid tests for transplant patient management.
- 21 CFR 866.3181 · Cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection.
- 21 CFR 866.3183 · Quantitative viral nucleic acid test for transplant patient management.
- 21 CFR 866.3200 · Echinococcus spp. serological reagents.
- 21 CFR 866.3205 · Echovirus serological reagents.
- 21 CFR 866.3210 · Endotoxin assay.
- 21 CFR 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 CFR 866.3220 · Entamoeba histolytica serological reagents.
- 21 CFR 866.3225 · Enterovirus nucleic acid assay.
- 21 CFR 866.3230 · Device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections.
- 21 CFR 866.3231 · Device to detect bacterial protease activity in chronic wound fluid.
- 21 CFR 866.3235 · Epstein-Barr virus serological reagents.
- 21 CFR 866.3236 · Device to detect or measure nucleic acid from viruses associated with head and neck cancers.
- 21 CFR 866.3240 · Equine encephalomyelitis virus serological reagents.
- 21 CFR 866.3250 · Erysipelothrix rhusiopathiae serological reagents.
- 21 CFR 866.3255 · Escherichia coli serological reagents.
- 21 CFR 866.3270 · Flavobacterium spp. serological reagents.
- 21 CFR 866.3280 · Francisella tularensis serological reagents.
- 21 CFR 866.3290 · Gonococcal antibody test (GAT).
- 21 CFR 866.3300 · Haemophilus spp. serological reagents.
- 21 CFR 866.3305 · Herpes simplex virus serological assays.
- 21 CFR 866.3307 · Herpes simplex virus nucleic acid-based assay for central nervous system infections.
- 21 CFR 866.3309 · Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
- 21 CFR 866.3310 · Hepatitis A virus (HAV) serological assays.
- 21 CFR 866.3320 · Histoplasma capsulatum serological reagents.
- 21 CFR 866.3328 · Influenza virus antigen detection test system.
- 21 CFR 866.3330 · Influenza virus serological reagents.
- 21 CFR 866.3332 · Reagents for detection of specific novel influenza A viruses.
- 21 CFR 866.3336 · John Cunningham Virus serological reagents.
- 21 CFR 866.3340 · Klebsiella spp. serological reagents.
- 21 CFR 866.3350 · Leptospira spp. serological reagents.
- 21 CFR 866.3355 · Listeria spp. serological reagents.
- 21 CFR 866.3360 · Lymphocytic choriomeningitis virus serological reagents.
- 21 CFR 866.3361 · Mass spectrometer system for clinical use for the identification of microorganisms.
- 21 CFR 866.3365 · Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
- 21 CFR 866.3367 · Device to detect and identify microbial nucleic acids by FISH in clinical specimens.
- 21 CFR 866.3370 · Mycobacterium tuberculosis immunofluorescent reagents.
- 21 CFR 866.3372 · Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
- 21 CFR 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 CFR 866.3375 · Mycoplasma spp. serological reagents.
- 21 CFR 866.3376 · Device to detect and identify fungal nucleic acids directly in respiratory specimens.
- 21 CFR 866.3378 · Clinical mass spectrometry microorganism identification and differentiation system.
- 21 CFR 866.3380 · Mumps virus serological reagents.
- 21 CFR 866.3390 · Neisseria spp. direct serological test reagents.
- 21 CFR 866.3393 · Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).
- 21 CFR 866.3395 · Norovirus serological reagents.
- 21 CFR 866.3400 · Parainfluenza virus serological reagents.
- 21 CFR 866.3402 · Plasmodium species antigen detection assays.
- 21 CFR 866.3405 · Poliovirus serological reagents.
- 21 CFR 866.3410 · Proteus spp. (Weil-Felix) serological reagents.
- 21 CFR 866.3415 · Pseudomonas spp. serological reagents.
- 21 CFR 866.3460 · Rabiesvirus immunofluorescent reagents.
- 21 CFR 866.3470 · Reovirus serological reagents.
- 21 CFR 866.3480 · Respiratory syncytial virus serological reagents.
- 21 CFR 866.3490 · Rhinovirus serological reagents.
- 21 CFR 866.3500 · Rickettsia serological reagents.
- 21 CFR 866.3510 · Rubella virus serological reagents.
- 21 CFR 866.3520 · Rubeola (measles) virus serological reagents.
- 21 CFR 866.3550 · Salmonella spp. serological reagents.
- 21 CFR 866.3600 · Schistosoma spp. serological reagents.
- 21 CFR 866.3630 · Serratia spp. serological reagents.
- 21 CFR 866.3660 · Shigella spp. serological reagents.
- 21 CFR 866.3680 · Sporothrix schenckii serological reagents.
- 21 CFR 866.3700 · Staphylococcus aureus serological reagents.
- 21 CFR 866.3720 · Streptococcus spp. exoenzyme reagents.
- 21 CFR 866.3740 · Streptococcus spp. serological reagents.
- 21 CFR 866.3780 · Toxoplasma gondii serological reagents.
- 21 CFR 866.3820 · Treponema pallidum nontreponemal test reagents.
- 21 CFR 866.3830 · Treponema pallidum treponemal test reagents.
- 21 CFR 866.3850 · Trichinella spiralis serological reagents.
- 21 CFR 866.3860 · Trichomonas vaginalis nucleic acid assay.
- 21 CFR 866.3870 · Trypanosoma spp. serological reagents.
- 21 CFR 866.3900 · Varicella-zoster virus serological reagents.
- 21 CFR 866.3920 · Assayed quality control material for clinical microbiology assays.
- 21 CFR 866.3930 · Vibrio cholerae serological reagents.
- 21 CFR 866.3935 · Zika virus serological reagents.