Microbiology

第 1 / 3 页

代码器械名称类别21 CFR近三年 510(k)
GLZAntigens, If, Toxoplasma Gondii第 2 类21 CFR 866.378018
GMAAntisera, Fluorescent, Sporothrix Schenekii第 1 类21 CFR 866.36801
GMBLight, Wood'S, Fluorescence第 1 类21 CFR 866.2600
GMDAntisera, Latex Agglutination, Cryptococcus Neoformans第 2 类21 CFR 866.316510
GMEAntisera, Fluorescent, Cryptococcus Neoformans第 2 类21 CFR 866.3165
GMGAntigen, Latex Agglutination, Coccidioides Immitis第 2 类21 CFR 866.31355
GMHAntiserum, Positive Control, Coccidioides Immitis第 2 类21 CFR 866.31355
GMIAntigen, Cf And / Or Id, Coccidioides Immitis第 2 类21 CFR 866.313511
GMJAntigens, Histoplasma Capsulatum, All第 2 类21 CFR 866.332012
GMKAntiserum, Positive Control, Histoplasma Capsulatum第 2 类21 CFR 866.33209
GMLAntisera, Fluorescent, Histoplasma Capsulatum第 2 类21 CFR 866.3320
GMMAntigens, Iha, Toxoplasma Gondii第 2 类21 CFR 866.37808
GMNAntigens, Cf, Toxoplasma Gondii第 2 类21 CFR 866.37803
GMOAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.第 2 类21 CFR 866.3220
GMPAntisera, Control For Nontreponemal Tests第 2 类21 CFR 866.38209
GMQAntigens, Nontreponemal, All第 2 类21 CFR 866.382032
GMRSera, Reactive And Non-Specific Control, Fta-Abs Test第 2 类21 CFR 866.3830
GMSAnti-Human Globulin, Fta-Abs Test第 2 类21 CFR 866.38303
GMTAntigens, Ha, Treponema Pallidum第 2 类21 CFR 866.38309
GMWTest, Sorbent, Fta-Abs第 2 类21 CFR 866.3830
GMXAntisera, Fluorescent Antibody For Fta-Abs Test第 2 类21 CFR 866.3830
GMYAntisera, Fluorescent, All Types, Escherichia Coli第 1 类21 CFR 866.32552
GMZAntigens, All Types, Escherichia Coli第 1 类21 CFR 866.325514
GNAAntisera, All Types, Escherichia Coli第 1 类21 CFR 866.325512
GNBAntisera, All Types, Shigella Spp.第 2 类21 CFR 866.366041
GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.第 2 类21 CFR 866.355060
GNDAntigen, Iha, T. Cruzi第 1 类21 CFR 866.3870
GNEAntigen, Latex Agglutination, T. Cruzi第 1 类21 CFR 866.38701
GNFAntigen, Cf, T. Cruzi第 1 类21 CFR 866.3870
GNGAntigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6第 1 类21 CFR 866.31452
GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni第 1 类21 CFR 866.36002
GNIAntisera, Neutralization, Echovirus 1-34第 1 类21 CFR 866.3205
GNJAntigens, Ha, Echovirus 1-34第 1 类21 CFR 866.32051
GNKAntisera, Cf, Echovirus 1-34第 1 类21 CFR 866.32053
GNLAntigens, Cf (Including Cf Control), Echovirus 1-34第 1 类21 CFR 866.32052
GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6第 1 类21 CFR 866.31459
GNNAntisera, Neutralization, Coxsackievirus A 1-24, B 1-6第 1 类21 CFR 866.31451
GNOAntisera, Cf, Coxsackievirus A 1-24, B 1-6第 1 类21 CFR 866.31451
GNPAntiserum, Cf, Epstein-Barr Virus第 1 类21 CFR 866.323520
GNQAntigen, Cf (Including Cf Control), Epstein-Barr Virus第 1 类21 CFR 866.3235
GNRAntisera, Neutralization, Influenza Virus A, B, C第 1 类21 CFR 866.33301
GNSAntisera, Hai, Influenza Virus A, B, C第 1 类21 CFR 866.33309
GNTAntigens, Ha (Including Ha Control), Influenza Virus A, B, C第 1 类21 CFR 866.33305
GNWAntisera, Cf, Influenza Virus A, B, C第 1 类21 CFR 866.333016
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C第 1 类21 CFR 866.333018
GNYAntisera, Fluorescent, Adenovirus 1-33第 1 类21 CFR 866.30204
GNZAntisera, Neutralization, Adenovirus 1-33第 1 类21 CFR 866.3020
GOAAntisera, Cf, Adenovirus 1-33第 1 类21 CFR 866.30201
GOBAntigens, Ha (Including Ha Control), Adenovirus 1-33第 1 类21 CFR 866.30201
GOCAntisera, Hai, Adenovirus 1-33第 1 类21 CFR 866.3020
GODAntigens, Cf (Including Cf Control), Adenovirus 1-33第 1 类21 CFR 866.302011
GOEAntisera, Fluorescent, Poliovirus 1-3第 1 类21 CFR 866.34057
GOFAntisera, Neutralization, Poliovirus 1-3第 1 类21 CFR 866.3405
GOGAntisera, Cf, Poliovirus 1-3第 1 类21 CFR 866.34053
GOHAntigens, Cf (Including Cf Control), Poliovirus 1-3第 1 类21 CFR 866.3405
GOIAntiserum, Fluorescent, Rabies Virus第 2 类21 CFR 866.34602
GOJAntisera, Neutralization, Rubella第 2 类21 CFR 866.3510
GOKAntisera, Hai (Including Hai Control), Rubella第 2 类21 CFR 866.351011
GOLAntigen, Ha (Including Ha Control), Rubella第 2 类21 CFR 866.351021
GOMAntisera, Cf, Rubella第 2 类21 CFR 866.35102
GONAntigen, Cf (Including Cf Control), Rubella第 2 类21 CFR 866.35105
GOOAntisera, Fluorescent, All Globulins, Salmonella Spp.第 2 类21 CFR 866.3550
GOPAntisera, C. Acnes (553, 605)第 1 类21 CFR 866.3140
GOSAntiserum, Fluorescent, C. Diphtheriae第 1 类21 CFR 866.3140
GOTAntigen, B. Parapertussis第 1 类21 CFR 866.3065
GOWAntisera, Agglutinating, B. Parapertussis第 1 类21 CFR 866.3065
GOXAntigen, B. Pertussis第 1 类21 CFR 866.30651
GOYAntisera, Agglutinating, B. Pertussis, All第 1 类21 CFR 866.30651
GOZAntisera, Fluorescent, B. Pertussis第 1 类21 CFR 866.3065
GPDAntigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus第 1 类21 CFR 866.3200
GPEAntisera, Positive Control, Echinococcus Spp.第 1 类21 CFR 866.3200
GPFAntigen, Agglutinating, Echinococcus Spp.第 1 类21 CFR 866.32001
GPGAntigen, Latex Agglutination, Trichinella Spiralis第 1 类21 CFR 866.38502
GPHAntiserum, Bentonite Flocculation, Trichinella Spiralis第 1 类21 CFR 866.3850
GPIAntigen, Bentonite Flocculation, Trichinella Spiralis第 1 类21 CFR 866.3850
GPJAntiserum, Fluorescent, Q Fever第 1 类21 CFR 866.35002
GPKAntiserum, Rickettsial Pox第 1 类21 CFR 866.3500
GPMAntiserum, Murine Typhus Fever第 1 类21 CFR 866.35001
GPNAntiserum, Typhus Fever第 1 类21 CFR 866.35001
GPOAntigen, Cf, Typhus Fever Group第 1 类21 CFR 866.35001
GPPAntiserum, Rocky Mountain Spotted Fever第 1 类21 CFR 866.35001
GPQAntigen, Cf, Spotted Fever Group第 1 类21 CFR 866.3500
GPRAntiserum, Cf, Q Fever第 1 类21 CFR 866.3500
GPSAntigen, Cf, Q Fever第 1 类21 CFR 866.35001
GPTAntiserum, Cf, Psittacosis (Chlamydia Group)第 1 类21 CFR 866.31201
GPWAntigen, Cf, Psittacosis (Chlamydia Group)第 1 类21 CFR 866.31204
GPXAntisera, Neutralizion, Reovirus 1-3第 1 类21 CFR 866.3470
GPYAntisera, Hai, Reovirus 1-3第 1 类21 CFR 866.3470
GPZAntisera, Cf, Reovirus 1-3第 1 类21 CFR 866.3470
GQAAntigens, Ha (Including Ha Control), Reovirus 1-3第 1 类21 CFR 866.3470
GQBAntigens, Cf (Including Cf Control), Reovirus 1-3第 1 类21 CFR 866.3470
GQCAntisera, Cf, Equine Encephalitis Virus, Eee, Wee第 1 类21 CFR 866.32402
GQDAntigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, W第 1 类21 CFR 866.3240
GQEAntisera, Neutralization, All Types, Rhinovirus第 1 类21 CFR 866.3490
GQFAntiserum, Neutralization, Respiratory Syncytial Virus第 1 类21 CFR 866.3480
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus第 1 类21 CFR 866.348032
GQHAntigen, Cf (Including Cf Control), Cytomegalovirus第 2 类21 CFR 866.317519
GQIAntiserum, Cf, Cytomegalovirus第 2 类21 CFR 866.317518
GQJAntiserum, Cf, Lymphocytic Choriomeningitis Virus第 1 类21 CFR 866.3360
GQKAntigen, Cf, Lymphocytic Choriomeningitis Virus第 1 类21 CFR 866.3360
GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2第 2 类21 CFR 866.330537
GQMAntisera, Neutralization, Herpesvirus Hominis第 2 类21 CFR 866.33053
GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2第 2 类21 CFR 866.330534
GQOAntisera, Cf, Herpesvirus Hominis 1,2第 2 类21 CFR 866.330516
GQPAntisera, Neutralization, Parainfluenza Virus 1-4第 1 类21 CFR 866.34002
GQQAntisera, Hai, Parainfluenza Virus 1-4第 1 类21 CFR 866.34001
GQRAntigens, Ha (Including Ha Control), Parainfluenza Virus 1-4第 1 类21 CFR 866.34001
GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-4第 1 类21 CFR 866.340011
GQTAntisera, Cf, Parainfluenza Virus 1-4第 1 类21 CFR 866.34004
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster第 2 类21 CFR 866.390010
GQXAntiserum, Cf, Varicella-Zoster第 2 类21 CFR 866.390011
GQYAntigen, Ha (Including Ha Control), Mumps Virus第 1 类21 CFR 866.3380
GQZAntiserum, Neutralization, Mumps Virus第 1 类21 CFR 866.3380
GRAAntiserum, Fluorescent, Mumps Virus第 1 类21 CFR 866.33803
GRBAntiserum, Cf, Mumps Virus第 1 类21 CFR 866.33802
GRCAntigen, Cf (Including Cf Control), Mumps Virus第 1 类21 CFR 866.33803
GRDAntiserum, Hai, Mumps Virus第 1 类21 CFR 866.33801
GREAntiserum, Fluorescent, Rubeola第 1 类21 CFR 866.35204
GRFAntiserum, Cf, Rubeola第 1 类21 CFR 866.35202
GRGAntiserum, Hai, Rubeola第 1 类21 CFR 866.3520
GRHAntigen, Ha (Including Ha Control), Rubeola第 1 类21 CFR 866.3520
GRIAntiserum, Neutralization, Rubeola第 1 类21 CFR 866.3520
GRJAntigen, Cf, (Including Cf Control), Rubeola第 1 类21 CFR 866.35202
GRKAntisera, Fluorescent, Echovirus 1-34第 1 类21 CFR 866.3205
GRLAntigens, All Groups, Salmonella Spp.第 2 类21 CFR 866.35502
GRMAntisera, All Groups, Salmonella Spp.第 2 类21 CFR 866.355069
GROAntisera, Fluorescent, All Types, Hemophilus Spp.第 2 类21 CFR 866.33004
GRPAntisera, All Types, H. Influenza第 2 类21 CFR 866.33006
GRTAntiserum, Fluorescent, Mycobacterium Tuberculosis第 1 类21 CFR 866.33701
GRWAntisera, All Fluorescent, Leptospira Spp.第 2 类21 CFR 866.3350
GRXAntisera, All Leptospira Spp.第 2 类21 CFR 866.3350
GRYAntigens, All, Leptospira Spp.第 2 类21 CFR 866.33502
GRZAntisera, Fluorescent, All, Mycoplasma Spp.第 1 类21 CFR 866.33755
GSAAntisera, All Mycoplasma Spp.第 1 类21 CFR 866.33756
GSBAntigens, Cf, All, Mycoplasma Spp.第 1 类21 CFR 866.33755
GSDAntiserum, Fluorescent, Erysipelothrix Rhusiopathiae第 1 类21 CFR 866.3250
GSEAntiserum, Erysipelothrix Rhusiopathiae第 1 类21 CFR 866.3250
GSFAntigen, Erysipelothrix Rhusiopathiae第 1 类21 CFR 866.3250
GSGAntisera, Fluorescent, All Types, Listeria Monocytogenes第 1 类21 CFR 866.3355
GSHAntisera, All Types, Listeria Monocytogenes第 1 类21 CFR 866.33551
GSIAntigens, Slide And Tube, All Types, Listeria Monocytogenes第 1 类21 CFR 866.33551
GSJAntiserum, Fluorescent, Francisella Tularensis第 2 类21 CFR 866.32801
GSKAntiserum, Francisella Tularensis第 2 类21 CFR 866.32801
GSLAntigens, Slide And Tube, Francisella Tularensis第 2 类21 CFR 866.32801
GSMAntisera, Fluorescent, Brucella Spp.第 2 类21 CFR 866.30854
GSNAntiserum, Positive And Negative Febrile Antigen Control Serum第 2 类21 CFR 866.30853
GSOAntigens (Febrile), Agglutination, Brucella Spp.第 2 类21 CFR 866.308512
GSPAntiserum, Fluorescent, Campylobacter Fetus第 1 类21 CFR 866.3110
GSQAntiserum, Vibrio Cholerae, All Varieties第 2 类21 CFR 866.39303
GSRAntisera, Fluorescent, Pseudomonas Pseudomallei第 2 类21 CFR 866.3415
GSSAntisera, Fluorescent, Pseudomonas Aeruginosa第 2 类21 CFR 866.34151
GSTAntiserum, Pseudomonas Pseudomallei第 2 类21 CFR 866.3415
GSWAntiserum, Flavobacterium Meningosepticum, All Groups第 1 类21 CFR 866.3270
GSXAntisera, Acinetobacter Calcoaceticus, All Varieties第 1 类21 CFR 866.3010
GSYAntisera, Fluorescent, All Globulins, Proteus Spp.第 1 类21 CFR 866.3410
GSZAntigens, Febrile (Weil-Felix), All Groups第 1 类21 CFR 866.34103
GTAAntisera, All, Serratia Marcesans第 1 类21 CFR 866.3630
GTBAntisera, Fluorescent, All Types, Klebsiella Spp.第 1 类21 CFR 866.3340
GTCAntisera, All Types, Klebsiella Spp.第 1 类21 CFR 866.33401
GTDAntisera, Fluorescent, All Globulins, Shigella Spp.第 2 类21 CFR 866.3660
GTEAntisera, Arizona Spp., All第 1 类21 CFR 866.3035
GTFAntisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.第 1 类21 CFR 866.3125
GTHAntiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae第 2 类21 CFR 866.33903
GTIAntisera, Fluorescent, All Groups, N. Meningitidis第 2 类21 CFR 866.33902
GTJAntisera, All Groups, N. Meningitidis第 2 类21 CFR 866.339016
GTLPhages, Staphylococcal Typing, All Types第 1 类21 CFR 866.2050
GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.第 1 类21 CFR 866.37004
GTOAnti-Streptokinase第 1 类21 CFR 866.3720
GTPExoenzymes, Multiple, Streptococcal第 1 类21 CFR 866.37203
GTQAntistreptolysin - Titer/Streptolysin O Reagent第 1 类21 CFR 866.372037
GTRAntideoxyribonuclease, Streptococcus Spp.第 1 类21 CFR 866.37201
GTXAntisera, Fluorescent, All Groups, Streptococcus Spp.第 1 类21 CFR 866.37402
GTYAntigens, All Groups, Streptococcus Spp.第 1 类21 CFR 866.374044
GTZAntisera, All Groups, Streptococcus Spp.第 1 类21 CFR 866.3740105
GWBAntisera, Fluorescent, All Types, Streptococcus Pneumoniae第 1 类21 CFR 866.37402
GWCAntisera, All Types, Streptococcus Pneumoniae第 1 类21 CFR 866.37409
GWDIndirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp第 2 类21 CFR 866.32202
JRWAntisera, Fluorescent, B. Parapertussis第 1 类21 CFR 866.30652
JRYAntiserum, Fluorescent, Epstein-Barr Virus第 1 类21 CFR 866.32359
JRZMedia, Culture, Amino Acid Assay第 1 类21 CFR 866.2350
JSACulture Media, Antibiotic Assay第 1 类21 CFR 866.23508
JSBCulture Media, Vitamin Assay第 1 类21 CFR 866.2350
JSCCulture Media, General Nutrient Broth第 1 类21 CFR 866.235052
JSDCulture Media, Selective Broth第 1 类21 CFR 866.236026
JSECulture Media, Multiple Biochemical Test第 1 类21 CFR 866.232053
JSFCulture Media, Single Biochemical Test第 1 类21 CFR 866.232087
JSGCulture Media, Non-Selective And Non-Differential第 1 类21 CFR 866.2300209
JSHCulture Media, Non-Selective And Differential第 1 类21 CFR 866.2320146
JSICulture Media, Selective And Differential第 1 类21 CFR 866.2360285
JSJCulture Media, Selective And Non-Differential第 1 类21 CFR 866.2360307
JSKSupplement, Culture Media第 1 类21 CFR 866.245070
JSLCulture Media, Anaerobic Transport第 1 类21 CFR 866.23908
JSMCulture Media, Non-Propagating Transport第 1 类21 CFR 866.2390111
JSNCulture Media, Propagating Transport第 1 类21 CFR 866.239013
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hi第 2 类21 CFR 866.170040
JSPKit, Anaerobic Identification第 1 类21 CFR 866.266018
JSRKit, Identification, Dermatophyte第 1 类21 CFR 866.26601
JSSKit, Identification, Enterobacteriaceae第 1 类21 CFR 866.266049
JSTKit, Fastidious Organisms第 1 类21 CFR 866.26606
JSWKit, Identification, Glucose Nonfermenter第 1 类21 CFR 866.26606