FDA医疗器械分类目录-​第866部分免疫学和微生物学设备

标题21--食品和药品
第一章--食品和药物管理局
卫生与公众服务
部 分章 h 分章 - 医疗器械

第866部分免疫学和微生物学设备

subpart a - generalprovisions

   § 866.1 - scope.
   § 866.3 - effective dates of re forpremarket approval.
   § 866.9 - limitations of exemptions fromsection 510(k) of the federal food, drug, and cosmetic act (theact).

subpart b - diagnostic devices
   § 866.1620 - antimicrobial susceptibilitytest disc.
   § 866.1640 - antimicrobial susceptibilitytest powder.
   § 866.1645 - fully automated short-termincubation cycle antimicrobial susceptibility system.
   § 866.1655 - system for detection ofmicroorganisms and antimicrobial resistance using reporterexpression.
   § 866.1700 - culture medium forantimicrobial susceptibility tests.

subpart c - microbiology devices
   § 866.2050 - staphylococcal typingbacteriophage.
   § 866.2120 - anaerobic chamber.
   § 866.2160 - coagulase plasma.
   § 866.2170 - automated colony counter.
   § 866.2180 - manual colony counter.
   § 866.2190 - automated image assessmentsystem for microbial colonies on solid culture media.
   § 866.2300 - multipurpose culturemedium.
   § 866.2320 - differential culturemedium.
   § 866.2330 - enriched culture medium.
   § 866.2350 - microbiological assay culturemedium.
   § 866.2360 - selective culture medium.
   § 866.2390 - transport culture medium.
   § 866.2410 - culture medium for pathogenicneisseria spp.
   § 866.2420 - oxidase screening test forgonorrhea.
   § 866.2440 - automated medium dispensing andstacking device.
   § 866.2450 - supplement for culturemedia.
   § 866.2480 - control kit for culturemedia.
   § 866.2500 - microtiter diluting anddispensing device.
   § 866.2540 - microbiological incubator.
   § 866.2560 - microbial growth monitor.
   § 866.2580 - gas-generating device.
   § 866.2600 - wood's fluorescent lamp.
   § 866.2660 - microorganism differentiationand identification device.
   § 866.2680 - streptococcus spp. nucleicacid-based assay.
   § 866.2850 - automated zone reader.
   § 866.2900 - microbiological specimencollection and transport device.

subpart d - serological reagents
   § 866.3010 - acinetobacter calcoaceticusserological reagents.
   § 866.3020 - adenovirus serologicalreagents.
   § 866.3035 - arizona spp. serologicalreagents.
   § 866.3040 - aspergillus spp. serologicalreagents.
   § 866.3045 - in vitro diagnostic devicefor bacillus spp. detection.
   § 866.3050 - beta-glucan serologicalassays.
   § 866.3060 - blastomyces dermatitidisserological reagents.
   § 866.3065 - bordetella spp. serologicalreagents.
   § 866.3085 - brucella spp. serologicalreagents.
   § 866.3110 - campylobacter fetus serologicalreagents.
   § 866.3120 - chlamydia serologicalreagents.
   § 866.3125 - citrobacter spp. serologicalreagents.
   § 866.3130 - clostridium difficile toxingene amplification assay.
   § 866.3135 - coccidioides immitisserological reagents.
   § 866.3140 - corynebacterium spp.serological reagents.
   § 866.3145 - coxsackievirus serologicalreagents.
   § 866.3165 - cryptococcus neoformansserological reagents.
   § 866.3169 - hepatitis c virus antibodytests.
   § 866.3170 - nucleic acid-based hepatitis cvirus ribonucleic acid tests.
   § 866.3175 - cytomegalovirus serologicalreagents.
   § 866.3200 - echinococcus spp. serologicalreagents.
   § 866.3205 - echovirus serologicalreagents.
   § 866.3210 - endotoxin assay.
   § 866.3215 - device to detect and measurenon-microbial analyte(s) in human clinical specimens to aid inassessment of patients with suspected sepsis.
   § 866.3220 - entamoeba histolyticaserological reagents.
   § 866.3225 - enterovirus nucleic acidassay.
   § 866.3235 - epstein-barr virus serologicalreagents.
   § 866.3240 - equine encephalomyelitis virusserological reagents.
   § 866.3250 - erysipelothrix rhusiopathiaeserological reagents.
   § 866.3255 - escherichia coli serologicalreagents.
   § 866.3270 - flavobacterium spp. serologicalreagents.
   § 866.3280 - francisella tularensisserological reagents.
   § 866.3290 - gonococcal antibody test(gat).
   § 866.3300 - haemophilus spp. serologicalreagents.
   § 866.3305 - herpes simplex virusserological assays.
   § 866.3309 - herpes virus nucleic acid-basedcutaneous and mucocutaneous lesion panel.
   § 866.3310 - hepatitis a virus (hav)serological assays.
   § 866.3320 - histoplasma capsulatumserological reagents.
   § 866.3328 - influenza virus antigendetection test system.
   § 866.3330 - influenza virus serologicalreagents.
   § 866.3332 - reagents for detection ofspecific novel influenza a viruses.
   § 866.3336 - john cunningham virusserological reagents.
   § 866.3340 - klebsiella spp. serologicalreagents.
   § 866.3350 - leptospira spp. serologicalreagents.
   § 866.3355 - listeria spp. serologicalreagents.
   § 866.3360 - lymphocytic choriomeningitisvirus serological reagents.
   § 866.3361 - mass spectrometer system forclinical use for the identification of microorganisms.
   § 866.3365 - multiplex nucleic acid assayfor identification of microorganisms and resistance markers frompositive blood cultures.
   § 866.3370 - mycobacterium tuberculosisimmunofluorescent reagents.
   § 866.3372 - nucleic acid-based in vitrodiagnostic devices for the detection of mycobacterium tuberculosiscomplex in respiratory specimens.
   § 866.3373 - nucleic acid-based in vitrodiagnostic devices for the detection of mycobacterium tuberculosiscomplex (mtb-complex) and the genetic mutations associated withmtb-complex antibiotic resistance in respiratory specimens.
   § 866.3375 - mycoplasma spp. serologicalreagents.
   § 866.3380 - mumps virus serologicalreagents.
   § 866.3390 - neisseria spp. directserological test reagents.
   § 866.3395 - norovirus serologicalreagents.
   § 866.3400 - parainfluenza virus serologicalreagents.
   § 866.3402 - plasmodium species antigendetection assays.
   § 866.3405 - poliovirus serologicalreagents.
   § 866.3410 - proteus spp. (weil-felix)serological reagents.
   § 866.3415 - pseudomonas spp. serologicalreagents.
   § 866.3460 - rabiesvirus immunofluorescentreagents.
   § 866.3470 - reovirus serologicalreagents.
   § 866.3480 - respiratory syncytial virusserological reagents.
   § 866.3490 - rhinovirus serologicalreagents.
   § 866.3500 - rickettsia serologicalreagents.
   § 866.3510 - rubella virus serologicalreagents.
   § 866.3520 - rubeola (measles) virusserological reagents.
   § 866.3550 - salmonella spp. serologicalreagents.
   § 866.3600 - schistosoma spp. serologicalreagents.
   § 866.3630 - serratia spp. serologicalreagents.
   § 866.3660 - shigella spp. serologicalreagents.
   § 866.3680 - sporothrix schenckiiserological reagents.
   § 866.3700 - staphylococcus aureusserological reagents.
   § 866.3720 - streptococcus spp. exoenzymereagents.
   § 866.3740 - streptococcus spp. serologicalreagents.
   § 866.3780 - toxoplasma gondii serologicalreagents.
   § 866.3820 - treponema pallidumnontreponemal test reagents.
   § 866.3830 - treponema pallidum treponemaltest reagents.
   § 866.3850 - trichinella spiralisserological reagents.
   § 866.3860 - trichomonas vaginalis nucleicacid assay.
   § 866.3870 - trypanosoma spp. serologicalreagents.
   § 866.3900 - varicella-zoster virusserological reagents.
   § 866.3920 - assayed controlmaterial for clinical microbiology assays.
   § 866.3930 - vibrio cholerae serologicalreagents.
   § 866.3940 - west nile virus serologicalreagents.
   § 866.3945 - dengue virus serologicalreagents.
   § 866.3946 - dengue virus nucleic acidamplification test reagents.
   § 866.3950 - in vitro human immunodeficiencyvirus (hiv) drug resistance genotype assay.
   § 866.3955 - human immunodeficiency virus(hiv) drug resistance genotyping assay using next generationse 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 forthe amplification, detection, and identification of microbialpathogens directly from whole blood specimens.
   § 866.3970 - device to detect and identifymicrobial pathogen nucleic acids in cerebrospinal fluid.
   § 866.3980 - respiratory viral panelmultiplex nucleic acid assay.
   § 866.3985 - device to detect and identifymicroorganisms and associated resistance marker nucleic acidsdirectly in respiratory specimens.
   § 866.3990 - gastrointestinal microorganismmultiplex nucleic acid-based assay.

subpart e - immunology laboratory e andreagents
   § 866.4070 - rna preanalytical systems.
   § 866.4100 - complement reagent.
   § 866.4500 - immunoelectrophoresise.
   § 866.4520 - immunofluorometere.
   § 866.4540 - immunonephelometere.
   § 866.4600 - ouchterlony agar plate.
   § 866.4700 - automated fluorescence in situhybridization (fish) enumeration systems.
   § 866.4750 - automated indirectimmunofluorescence microscope and software-assisted system.
   § 866.4800 - radial immunodiffusionplate.
   § 866.4830 - rocket immunoelectrophoresise.
   § 866.4900 - support gel.

subpart f - immunological test systems
   § 866.5040 - albumin immunological testsystem.
   § 866.5060 - prealbumin immunological testsystem.
   § 866.5065 - human allotypic markerimmunological test system.
   § 866.5080 - alpha-1-antichymotrypsinimmunological test system.
   § 866.5090 - antimitochondrial antibodyimmunological test system.
   § 866.5100 - antinuclear antibodyimmunological test system.
   § 866.5110 - antiparietal antibodyimmunological test system.
   § 866.5120 - antismooth muscle antibodyimmunological test system.
   § 866.5130 - alpha-1-antitrypsinimmunological test system.
   § 866.5150 - bence-jones proteinsimmunological test system.
   § 866.5160 - beta-globulin immunologicaltest system.
   § 866.5170 - breast milk immunological testsystem.
   § 866.5180 - fecal calprotectinimmunological test system.
   § 866.5200 - carbonic anhydrase b and cimmunological test system.
   § 866.5210 - ceruloplasmin immunologicaltest system.
   § 866.5220 - cohn fraction ii immunologicaltest system.
   § 866.5230 - colostrum immunological testsystem.
   § 866.5240 - complement componentsimmunological test system.
   § 866.5250 - complement c1 inhibitor(inactivator) immunological test system.
   § 866.5260 - complement c3b inactivatorimmunological test system.
   § 866.5270 - c-reactive proteinimmunological test system.
   § 866.5320 - properdin factor bimmunological test system.
   § 866.5330 - factor xiii, a, s,immunological test system.
   § 866.5340 - ferritin immunological testsystem.
   § 866.5350 - fibrinopeptide a immunologicaltest system.
   § 866.5360 - cohn fraction iv immunologicaltest system.
   § 866.5370 - cohn fraction v immunologicaltest system.
   § 866.5380 - free secretory componentimmunological test system.
   § 866.5400 - alpha-globulin immunologicaltest system.
   § 866.5420 - alpha-1-glycoproteinsimmunological test system.
   § 866.5425 - alpha-2-glycoproteinsimmunological test system.
   § 866.5430 - beta-2-glycoprotein iimmunological test system.
   § 866.5440 - beta-2-glycoprotein iiiimmunological test system.
   § 866.5460 - haptoglobin immunological testsystem.
   § 866.5470 - hemoglobin immunological testsystem.
   § 866.5490 - hemopexin immunological testsystem.
   § 866.5500 - hypersensitivity pneumonitisimmunological test system.
   § 866.5510 - immunoglobulins a, g, m, d, ande immunological test system.
   § 866.5520 - immunoglobulin g (fab fragmentspecific) immunological test system.
   § 866.5530 - immunoglobulin g (fc fragmentspecific) immunological test system.
   § 866.5540 - immunoglobulin g (fd fragmentspecific) immunological test system.
   § 866.5550 - immunoglobulin (light chainspecific) immunological test system.
   § 866.5560 - lactic dehydrogenaseimmunological test system.
   § 866.5570 - lactoferrin immunological testsystem.
   § 866.5580 - alpha-1-lipoproteinimmunological test system.
   § 866.5590 - lipoprotein x immunologicaltest system.
   § 866.5600 - low-density lipoproteinimmunological test system.
   § 866.5620 - alpha-2-macroglobulinimmunological test system.
   § 866.5630 - beta-2-microglobulinimmunological test system.
   § 866.5640 - infectious mononucleosisimmunological test system.
   § 866.5660 - multiple autoantibodiesimmunological test system.
   § 866.5665 - a autoantibodyimmunological test system.
   § 866.5670 - zinc transporter 8 autoantibodyimmunological test system.
   § 866.5680 - myoglobin immunological testsystem.
   § 866.5700 - whole human plasma or serumimmunological test system.
   § 866.5715 - plasminogen immunological testsystem.
   § 866.5735 - prothrombin immunological testsystem.
   § 866.5750 - radioallergosorbent (rast)immunological test system.
   § 866.5760 - tryptase test system.
   § 866.5765 - retinol-binding proteinimmunological test system.
   § 866.5775 - rheumatoid factor immunologicaltest system.
   § 866.5785 - anti-saccharomyces cerevisiae(s. cerevisiae) antibody (asca) test systems.
   § 866.5800 - seminal fluid (sperm)immunological test system.
   § 866.5820 - systemic lupus erythematosusimmunological test system.
   § 866.5830 - brain trauma assessmenttest.
   § 866.5860 - total spinal fluidimmunological test system.
   § 866.5870 - thyroid autoantibodyimmunological test system.
   § 866.5880 - transferrin immunological testsystem.
   § 866.5890 - inter-alpha trypsin inhibitorimmunological test system.
   § 866.5900 - cystic fibrosis transmembraneconductance regulator (cftr) gene mutation detection system.
   § 866.5910 - control material forcystic fibrosis nucleic acid assays.
   § 866.5930 - newborn screening test forsevere combined immunodeficiency disorder (scid).
   § 866.5940 - autosomal recessive carrierscreening gene mutation detection system.
   § 866.5950 - genetic health risk assessmentsystem.
   § 866.5960 - human leukocyte antigen typingcompanion diagnostic test.

subpart g - tumor associated antigen immunological testsystems
   § 866.6010 - tumor-associated antigenimmunological test system.
   § 866.6020 - immunomagnetic circulatingcancer cell selection and enumeration system.
   § 866.6030 - afp-l3% immunological testsystem.
   § 866.6040 - gene expression profiling testsystem for breast cancer prognosis.
   § 866.6050 - ovarian adnexal mass assessmentscore test system.
   § 866.6060 - bcr-abl test.
   § 866.6080 - next generation sebased tumor profiling test.