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Section 866.1
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Effective dates of requirement for premarket approval |
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Section 866.3
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Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) |
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Section 866.9
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Antimicrobial susceptibility test disc |
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Section 866.1620
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Antimicrobial susceptibility test powder |
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Section 866.1640
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Fully automated short-term incubation cycle antimicrobial susceptibility system |
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Section 866.1645
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Culture medium for antimicrobial susceptibility tests |
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Section 866.1700
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Staphylococcal typing bacteriophage |
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Section 866.2050
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Anaerobic chamber |
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Section 866.2120
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Coagulase plasma |
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Section 866.2160
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Automated colony counter |
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Section 866.2170
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Manual colony counter |
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Section 866.2180
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Multipurpose culture medium |
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Section 866.2300
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Differential culture medium |
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Section 866.2320
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Enriched culture medium |
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Section 866.2330
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Microbiological assay culture medium |
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Section 866.2350
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Selective culture medium |
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Section 866.2360
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Transport culture medium |
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Section 866.2390
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Culture medium for pathogenic Neisseria spp |
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Section 866.2410
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Oxidase screening test for gonorrhea |
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Section 866.2420
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Automated medium dispensing and stacking device |
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Section 866.2440
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Supplement for culture media |
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Section 866.2450
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Quality control kit for culture media |
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Section 866.2480
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Microtiter diluting and dispensing device |
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Section 866.2500
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Microbiological incubator |
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Section 866.2540
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Microbial growth monitor |
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Section 866.2560
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Gas-generating device |
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Section 866.2580
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Wood's fluorescent lamp |
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Section 866.2600
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Microorganism differentiation and identification device |
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Section 866.2660
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Automated zone reader |
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Section 866.2850
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Microbiological specimen collection and transport device |
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Section 866.2900
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Acinetobacter calcoaceticus serological reagents |
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Section 866.3010
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Adenovirus serological reagents |
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Section 866.3020
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Arizona spp |
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Section 866.3035
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Aspergillus spp |
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Section 866.3040
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Beta-glucan serological assays |
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Section 866.3050
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Blastomyces dermatitidis serological reagents |
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Section 866.3060
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Bordetella spp |
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Section 866.3065
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Brucella spp |
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Section 866.3085
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Campylobacter fetus serological reagents |
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Section 866.3110
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Chlamydia serological reagents |
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Section 866.3120
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Citrobacter spp |
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Section 866.3125
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Coccidioides immitis serological reagents |
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Section 866.3135
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Corynebacterium spp |
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Section 866.3140
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Coxsackievirus serological reagents |
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Section 866.3145
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Cryptococcus neoformans serological reagents |
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Section 866.3165
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Cytomegalovirus serological reagents |
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Section 866.3175
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Echinococcus spp |
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Section 866.3200
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Echovirus serological reagents |
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Section 866.3205
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Endotoxin assay |
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Section 866.3210
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Entamoeba histolytica serological reagents |
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Section 866.3220
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Enterovirus nucleic acid assay |
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Section 866.3225
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Epstein-Barr virus serological reagents |
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Section 866.3235
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Equine encephalomyelitis virus serological reagents |
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Section 866.3240
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Erysipelothrix rhusiopathiae serological reagents |
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Section 866.3250
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Escherichia coli serological reagents |
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Section 866.3255
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Flavobacterium spp |
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Section 866.3270
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Francisella tularensis serological reagents |
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Section 866.3280
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Gonococcal antibody test (GAT) |
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Section 866.3290
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Haemophilus spp |
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Section 866.3300
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Herpes simplex virus serological assays |
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Section 866.3305
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Hepatitis A virus (HAV) serological assays |
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Section 866.3310
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Histoplasma capsulatum serological reagents |
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Section 866.3320
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Influenza virus serological reagents |
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Section 866.3330
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Reagents for detection of specific novel influenza A viruses |
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Section 866.3332
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John Cunningham Virus serological reagents |
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Section 866.3336
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Klebsiella spp |
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Section 866.3340
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Leptospira spp |
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Section 866.3350
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Listeria spp |
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Section 866.3355
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Lymphocytic choriomeningitis virus serological reagents |
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Section 866.3360
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Mycobacterium tuberculosis immunofluorescent reagents |
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Section 866.3370
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Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory |
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Section 866.3372
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Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) |
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Section 866.3373
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Mycoplasma spp |
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Section 866.3375
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Mumps virus serological reagents |
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Section 866.3380
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Neisseria spp |
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Section 866.3390
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Norovirus serological reagents |
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Section 866.3395
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Parainfluenza virus serological reagents |
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Section 866.3400
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Plasmodium species antigen detection assays |
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Section 866.3402
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Poliovirus serological reagents |
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Section 866.3405
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Proteus spp |
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Section 866.3410
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Pseudomonas spp |
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Section 866.3415
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Rabiesvirus immuno fluorescent reagents |
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Section 866.3460
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Reovirus serological reagents |
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Section 866.3470
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Respiratory syncytial virus serological reagents |
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Section 866.3480
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Rhinovirus serological reagents |
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Section 866.3490
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Rickettsia serological reagents |
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Section 866.3500
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Rubella virus serological reagents |
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Section 866.3510
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Rubeola (measles) virus serological reagents |
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Section 866.3520
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Salmonella spp |
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Section 866.3550
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Schistosoma spp |
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Section 866.3600
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Serratia spp |
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Section 866.3630
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Shigella spp |
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Section 866.3660
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Sporothrix schenckii serological reagents |
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Section 866.3680
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Staphylococcus aureus serological reagents |
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Section 866.3700
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Streptococcus spp |
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Section 866.3720
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Streptococcus spp |
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Section 866.3740
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Toxoplasma gondii serological reagents |
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Section 866.3780
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Treponema pallidum non treponemal test reagents |
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Section 866.3820
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Treponema pallidum tre ponemal test reagents |
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Section 866.3830
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Trichinella spiralis serological reagents |
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Section 866.3850
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Trypanosoma spp |
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Section 866.3870
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Varicella-zoster virus serological reagents |
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Section 866.3900
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Vibrio cholerae serological reagents |
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Section 866.3930
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West Nile virus serological reagents |
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Section 866.3940
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Dengue virus serological reagents |
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Section 866.3945
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Dengue virus nucleic acid amplification test reagents |
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Section 866.3946
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In vitro human immunodeficiency virus (HIV) drug resistance genotype assay |
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Section 866.3950
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Respiratory viral panel multiplex nucleic acid assay |
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Section 866.3980
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RNA Preanalytical Systems |
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Section 866.4070
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Complement reagent |
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Section 866.4100
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Immunoelectrophoresis equipment |
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Section 866.4500
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Immunofluorometer equipment |
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Section 866.4520
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Immunonephelometer equipment |
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Section 866.4540
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Ouchterlony agar plate |
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Section 866.4600
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Automated fluorescence in situ hybridization (FISH) enumeration systems |
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Section 866.4700
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Radial immunodiffusion plate |
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Section 866.4800
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Rocket immunoelectro phoresis equipment |
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Section 866.4830
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Support gel |
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Section 866.4900
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Albumin immunological test system |
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Section 866.5040
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Prealbumin immunological test system |
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Section 866.5060
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Human allotypic marker immunological test system |
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Section 866.5065
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Alpha-1-antichymotrypsin immunological test system |
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Section 866.5080
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Antimitochondrial antibody immunological test system |
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Section 866.5090
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Antinuclear antibody immunological test system |
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Section 866.5100
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Antiparietal antibody immunological test system |
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Section 866.5110
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Antismooth muscle antibody immunological test system |
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Section 866.5120
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Alpha-1-antitrypsin immunological test system |
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Section 866.5130
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Bence-Jones proteins immunological test system |
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Section 866.5150
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Beta-globulin immunolog ical test system |
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Section 866.5160
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Breast milk immunological test system |
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Section 866.5170
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Fecal calprotectin immunological test system |
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Section 866.5180
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Carbonic anhydrase B and C immunological test system |
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Section 866.5200
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Ceruloplasmin immunolog ical test system |
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Section 866.5210
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Cohn fraction II immunolog ical test system |
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Section 866.5220
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Colostrum immunological test system |
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Section 866.5230
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Complement components immunological test system |
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Section 866.5240
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Complement C [bdi2] inhibitor (inactivator) immunological test system |
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Section 866.5250
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Complement C3b inactivator immunological test system |
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Section 866.5260
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C-reactive protein immuno logical test system |
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Section 866.5270
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Properdin factor B immuno logical test system |
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Section 866.5320
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Factor XIII, A, S, immuno logical test system |
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Section 866.5330
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Ferritin immunological test system |
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Section 866.5340
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Fibrinopeptide A immuno logical test system |
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Section 866.5350
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Cohn fraction IV immuno logical test system |
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Section 866.5360
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Cohn fraction V immuno logical test system |
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Section 866.5370
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Free secretory component immuno logical test system |
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Section 866.5380
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Alpha-globulin immuno logical test system |
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Section 866.5400
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Alpha-1-glycoproteins immunological test system |
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Section 866.5420
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Alpha-2-glycoproteins immunological test system |
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Section 866.5425
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Beta-2-glycoprotein I immunological test system |
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Section 866.5430
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Beta-2-glycoprotein III immunological test system |
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Section 866.5440
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Haptoglobin immunological test system |
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Section 866.5460
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Hemoglobin immunological test system |
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Section 866.5470
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Hemopexin immunological test system |
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Section 866.5490
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Hypersensitivity pneumonitis immunological test system |
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Section 866.5500
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Immunoglobulins A, G, M, D, and E immunological test system |
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Section 866.5510
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Immunoglobulin G (Fab fragment specific) immunological test system |
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Section 866.5520
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Immunoglobulin G (Fc fragment specific) immunological test system |
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Section 866.5530
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Immunoglobulin G (Fd fragment specific) immunological test system |
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Section 866.5540
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Immunoglobulin (light chain specific) immunological test system |
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Section 866.5550
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Lactic dehydrogenase immunological test system |
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Section 866.5560
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Lactoferrin immunological test system |
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Section 866.5570
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Alpha-1-lipoprotein immuno logical test system |
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Section 866.5580
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Lipoprotein X immunolog ical test system |
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Section 866.5590
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Low-density lipoprotein immunological test system |
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Section 866.5600
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Alpha-2-macroglobulin immunological test system |
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Section 866.5620
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Beta-2-microglobulin immunological test system |
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Section 866.5630
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Infectious mononucleosis immunological test system |
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Section 866.5640
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Multiple autoantibodies immunological test system |
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Section 866.5660
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Myoglobin immunological test system |
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Section 866.5680
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Whole human plasma or serum immunological test system |
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Section 866.5700
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Plasminogen immunological test system |
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Section 866.5715
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Prothrombin immunological test system |
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Section 866.5735
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Radioallergosorbent (RAST) immunological test system |
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Section 866.5750
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Tryptase test system |
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Section 866.5760
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Retinol-binding protein immunological test system |
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Section 866.5765
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Rheumatoid factor immuno logical test system |
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Section 866.5775
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Anti-Saccharomyces cerevisiae (S |
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Section 866.5785
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Seminal fluid (sperm) immunological test system |
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Section 866.5800
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Systemic lupus erythema tosus immunological test system |
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Section 866.5820
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Total spinal fluid immuno logical test system |
|
Section 866.5860
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Thyroid autoantibody immunological test system |
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Section 866.5870
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Transferrin immunological test system |
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Section 866.5880
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Inter-alpha trypsin inhibitor immunological test system |
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Section 866.5890
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Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system |
|
Section 866.5900
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Quality control material for cystic fibrosis nucleic acid assays |
|
Section 866.5910
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Tumor-associated antigen immunological test system |
|
Section 866.6010
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Immunomagnetic circulating cancer cell selection and enumeration system |
|
Section 866.6020
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AFP-L3% immunological test system |
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Section 866.6030
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Gene expression profiling test system for breast cancer prognosis |
|
Section 866.6040
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Ovarian adnexal mass assessment score test system |
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Section 866.6050
|
Scope |