Microbiology

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Code	Device name	Class	21 CFR	510(k) (3y)
GLZ	Antigens, If, Toxoplasma Gondii	Class 2	21 CFR 866.3780	18
GMA	Antisera, Fluorescent, Sporothrix Schenekii	Class 1	21 CFR 866.3680	1
GMB	Light, Wood'S, Fluorescence	Class 1	21 CFR 866.2600
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Class 2	21 CFR 866.3165	10
GME	Antisera, Fluorescent, Cryptococcus Neoformans	Class 2	21 CFR 866.3165
GMG	Antigen, Latex Agglutination, Coccidioides Immitis	Class 2	21 CFR 866.3135	5
GMH	Antiserum, Positive Control, Coccidioides Immitis	Class 2	21 CFR 866.3135	5
GMI	Antigen, Cf And / Or Id, Coccidioides Immitis	Class 2	21 CFR 866.3135	11
GMJ	Antigens, Histoplasma Capsulatum, All	Class 2	21 CFR 866.3320	12
GMK	Antiserum, Positive Control, Histoplasma Capsulatum	Class 2	21 CFR 866.3320	9
GML	Antisera, Fluorescent, Histoplasma Capsulatum	Class 2	21 CFR 866.3320
GMM	Antigens, Iha, Toxoplasma Gondii	Class 2	21 CFR 866.3780	8
GMN	Antigens, Cf, Toxoplasma Gondii	Class 2	21 CFR 866.3780	3
GMO	Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.	Class 2	21 CFR 866.3220
GMP	Antisera, Control For Nontreponemal Tests	Class 2	21 CFR 866.3820	9
GMQ	Antigens, Nontreponemal, All	Class 2	21 CFR 866.3820	32
GMR	Sera, Reactive And Non-Specific Control, Fta-Abs Test	Class 2	21 CFR 866.3830
GMS	Anti-Human Globulin, Fta-Abs Test	Class 2	21 CFR 866.3830	3
GMT	Antigens, Ha, Treponema Pallidum	Class 2	21 CFR 866.3830	9
GMW	Test, Sorbent, Fta-Abs	Class 2	21 CFR 866.3830
GMX	Antisera, Fluorescent Antibody For Fta-Abs Test	Class 2	21 CFR 866.3830
GMY	Antisera, Fluorescent, All Types, Escherichia Coli	Class 1	21 CFR 866.3255	2
GMZ	Antigens, All Types, Escherichia Coli	Class 1	21 CFR 866.3255	14
GNA	Antisera, All Types, Escherichia Coli	Class 1	21 CFR 866.3255	12
GNB	Antisera, All Types, Shigella Spp.	Class 2	21 CFR 866.3660	41
GNC	Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.	Class 2	21 CFR 866.3550	60
GND	Antigen, Iha, T. Cruzi	Class 1	21 CFR 866.3870
GNE	Antigen, Latex Agglutination, T. Cruzi	Class 1	21 CFR 866.3870	1
GNF	Antigen, Cf, T. Cruzi	Class 1	21 CFR 866.3870
GNG	Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6	Class 1	21 CFR 866.3145	2
GNH	Antigen, Fluorescent Antibody Test, Schistosoma Mansoni	Class 1	21 CFR 866.3600	2
GNI	Antisera, Neutralization, Echovirus 1-34	Class 1	21 CFR 866.3205
GNJ	Antigens, Ha, Echovirus 1-34	Class 1	21 CFR 866.3205	1
GNK	Antisera, Cf, Echovirus 1-34	Class 1	21 CFR 866.3205	3
GNL	Antigens, Cf (Including Cf Control), Echovirus 1-34	Class 1	21 CFR 866.3205	2
GNM	Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6	Class 1	21 CFR 866.3145	9
GNN	Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6	Class 1	21 CFR 866.3145	1
GNO	Antisera, Cf, Coxsackievirus A 1-24, B 1-6	Class 1	21 CFR 866.3145	1
GNP	Antiserum, Cf, Epstein-Barr Virus	Class 1	21 CFR 866.3235	20
GNQ	Antigen, Cf (Including Cf Control), Epstein-Barr Virus	Class 1	21 CFR 866.3235
GNR	Antisera, Neutralization, Influenza Virus A, B, C	Class 1	21 CFR 866.3330	1
GNS	Antisera, Hai, Influenza Virus A, B, C	Class 1	21 CFR 866.3330	9
GNT	Antigens, Ha (Including Ha Control), Influenza Virus A, B, C	Class 1	21 CFR 866.3330	5
GNW	Antisera, Cf, Influenza Virus A, B, C	Class 1	21 CFR 866.3330	16
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Class 1	21 CFR 866.3330	18
GNY	Antisera, Fluorescent, Adenovirus 1-33	Class 1	21 CFR 866.3020	4
GNZ	Antisera, Neutralization, Adenovirus 1-33	Class 1	21 CFR 866.3020
GOA	Antisera, Cf, Adenovirus 1-33	Class 1	21 CFR 866.3020	1
GOB	Antigens, Ha (Including Ha Control), Adenovirus 1-33	Class 1	21 CFR 866.3020	1
GOC	Antisera, Hai, Adenovirus 1-33	Class 1	21 CFR 866.3020
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Class 1	21 CFR 866.3020	11
GOE	Antisera, Fluorescent, Poliovirus 1-3	Class 1	21 CFR 866.3405	7
GOF	Antisera, Neutralization, Poliovirus 1-3	Class 1	21 CFR 866.3405
GOG	Antisera, Cf, Poliovirus 1-3	Class 1	21 CFR 866.3405	3
GOH	Antigens, Cf (Including Cf Control), Poliovirus 1-3	Class 1	21 CFR 866.3405
GOI	Antiserum, Fluorescent, Rabies Virus	Class 2	21 CFR 866.3460	2
GOJ	Antisera, Neutralization, Rubella	Class 2	21 CFR 866.3510
GOK	Antisera, Hai (Including Hai Control), Rubella	Class 2	21 CFR 866.3510	11
GOL	Antigen, Ha (Including Ha Control), Rubella	Class 2	21 CFR 866.3510	21
GOM	Antisera, Cf, Rubella	Class 2	21 CFR 866.3510	2
GON	Antigen, Cf (Including Cf Control), Rubella	Class 2	21 CFR 866.3510	5
GOO	Antisera, Fluorescent, All Globulins, Salmonella Spp.	Class 2	21 CFR 866.3550
GOP	Antisera, C. Acnes (553, 605)	Class 1	21 CFR 866.3140
GOS	Antiserum, Fluorescent, C. Diphtheriae	Class 1	21 CFR 866.3140
GOT	Antigen, B. Parapertussis	Class 1	21 CFR 866.3065
GOW	Antisera, Agglutinating, B. Parapertussis	Class 1	21 CFR 866.3065
GOX	Antigen, B. Pertussis	Class 1	21 CFR 866.3065	1
GOY	Antisera, Agglutinating, B. Pertussis, All	Class 1	21 CFR 866.3065	1
GOZ	Antisera, Fluorescent, B. Pertussis	Class 1	21 CFR 866.3065
GPD	Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus	Class 1	21 CFR 866.3200
GPE	Antisera, Positive Control, Echinococcus Spp.	Class 1	21 CFR 866.3200
GPF	Antigen, Agglutinating, Echinococcus Spp.	Class 1	21 CFR 866.3200	1
GPG	Antigen, Latex Agglutination, Trichinella Spiralis	Class 1	21 CFR 866.3850	2
GPH	Antiserum, Bentonite Flocculation, Trichinella Spiralis	Class 1	21 CFR 866.3850
GPI	Antigen, Bentonite Flocculation, Trichinella Spiralis	Class 1	21 CFR 866.3850
GPJ	Antiserum, Fluorescent, Q Fever	Class 1	21 CFR 866.3500	2
GPK	Antiserum, Rickettsial Pox	Class 1	21 CFR 866.3500
GPM	Antiserum, Murine Typhus Fever	Class 1	21 CFR 866.3500	1
GPN	Antiserum, Typhus Fever	Class 1	21 CFR 866.3500	1
GPO	Antigen, Cf, Typhus Fever Group	Class 1	21 CFR 866.3500	1
GPP	Antiserum, Rocky Mountain Spotted Fever	Class 1	21 CFR 866.3500	1
GPQ	Antigen, Cf, Spotted Fever Group	Class 1	21 CFR 866.3500
GPR	Antiserum, Cf, Q Fever	Class 1	21 CFR 866.3500
GPS	Antigen, Cf, Q Fever	Class 1	21 CFR 866.3500	1
GPT	Antiserum, Cf, Psittacosis (Chlamydia Group)	Class 1	21 CFR 866.3120	1
GPW	Antigen, Cf, Psittacosis (Chlamydia Group)	Class 1	21 CFR 866.3120	4
GPX	Antisera, Neutralizion, Reovirus 1-3	Class 1	21 CFR 866.3470
GPY	Antisera, Hai, Reovirus 1-3	Class 1	21 CFR 866.3470
GPZ	Antisera, Cf, Reovirus 1-3	Class 1	21 CFR 866.3470
GQA	Antigens, Ha (Including Ha Control), Reovirus 1-3	Class 1	21 CFR 866.3470
GQB	Antigens, Cf (Including Cf Control), Reovirus 1-3	Class 1	21 CFR 866.3470
GQC	Antisera, Cf, Equine Encephalitis Virus, Eee, Wee	Class 1	21 CFR 866.3240	2
GQD	Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, W	Class 1	21 CFR 866.3240
GQE	Antisera, Neutralization, All Types, Rhinovirus	Class 1	21 CFR 866.3490
GQF	Antiserum, Neutralization, Respiratory Syncytial Virus	Class 1	21 CFR 866.3480
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Class 1	21 CFR 866.3480	32
GQH	Antigen, Cf (Including Cf Control), Cytomegalovirus	Class 2	21 CFR 866.3175	19
GQI	Antiserum, Cf, Cytomegalovirus	Class 2	21 CFR 866.3175	18
GQJ	Antiserum, Cf, Lymphocytic Choriomeningitis Virus	Class 1	21 CFR 866.3360
GQK	Antigen, Cf, Lymphocytic Choriomeningitis Virus	Class 1	21 CFR 866.3360
GQL	Antisera, Fluorescent, Herpesvirus Hominis 1,2	Class 2	21 CFR 866.3305	37
GQM	Antisera, Neutralization, Herpesvirus Hominis	Class 2	21 CFR 866.3305	3
GQN	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2	Class 2	21 CFR 866.3305	34
GQO	Antisera, Cf, Herpesvirus Hominis 1,2	Class 2	21 CFR 866.3305	16
GQP	Antisera, Neutralization, Parainfluenza Virus 1-4	Class 1	21 CFR 866.3400	2
GQQ	Antisera, Hai, Parainfluenza Virus 1-4	Class 1	21 CFR 866.3400	1
GQR	Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4	Class 1	21 CFR 866.3400	1
GQS	Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	Class 1	21 CFR 866.3400	11
GQT	Antisera, Cf, Parainfluenza Virus 1-4	Class 1	21 CFR 866.3400	4
GQW	Antigen, Cf, (Including Cf Control), Varicella-Zoster	Class 2	21 CFR 866.3900	10
GQX	Antiserum, Cf, Varicella-Zoster	Class 2	21 CFR 866.3900	11
GQY	Antigen, Ha (Including Ha Control), Mumps Virus	Class 1	21 CFR 866.3380
GQZ	Antiserum, Neutralization, Mumps Virus	Class 1	21 CFR 866.3380
GRA	Antiserum, Fluorescent, Mumps Virus	Class 1	21 CFR 866.3380	3
GRB	Antiserum, Cf, Mumps Virus	Class 1	21 CFR 866.3380	2
GRC	Antigen, Cf (Including Cf Control), Mumps Virus	Class 1	21 CFR 866.3380	3
GRD	Antiserum, Hai, Mumps Virus	Class 1	21 CFR 866.3380	1
GRE	Antiserum, Fluorescent, Rubeola	Class 1	21 CFR 866.3520	4
GRF	Antiserum, Cf, Rubeola	Class 1	21 CFR 866.3520	2
GRG	Antiserum, Hai, Rubeola	Class 1	21 CFR 866.3520
GRH	Antigen, Ha (Including Ha Control), Rubeola	Class 1	21 CFR 866.3520
GRI	Antiserum, Neutralization, Rubeola	Class 1	21 CFR 866.3520
GRJ	Antigen, Cf, (Including Cf Control), Rubeola	Class 1	21 CFR 866.3520	2
GRK	Antisera, Fluorescent, Echovirus 1-34	Class 1	21 CFR 866.3205
GRL	Antigens, All Groups, Salmonella Spp.	Class 2	21 CFR 866.3550	2
GRM	Antisera, All Groups, Salmonella Spp.	Class 2	21 CFR 866.3550	69
GRO	Antisera, Fluorescent, All Types, Hemophilus Spp.	Class 2	21 CFR 866.3300	4
GRP	Antisera, All Types, H. Influenza	Class 2	21 CFR 866.3300	6
GRT	Antiserum, Fluorescent, Mycobacterium Tuberculosis	Class 1	21 CFR 866.3370	1
GRW	Antisera, All Fluorescent, Leptospira Spp.	Class 2	21 CFR 866.3350
GRX	Antisera, All Leptospira Spp.	Class 2	21 CFR 866.3350
GRY	Antigens, All, Leptospira Spp.	Class 2	21 CFR 866.3350	2
GRZ	Antisera, Fluorescent, All, Mycoplasma Spp.	Class 1	21 CFR 866.3375	5
GSA	Antisera, All Mycoplasma Spp.	Class 1	21 CFR 866.3375	6
GSB	Antigens, Cf, All, Mycoplasma Spp.	Class 1	21 CFR 866.3375	5
GSD	Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae	Class 1	21 CFR 866.3250
GSE	Antiserum, Erysipelothrix Rhusiopathiae	Class 1	21 CFR 866.3250
GSF	Antigen, Erysipelothrix Rhusiopathiae	Class 1	21 CFR 866.3250
GSG	Antisera, Fluorescent, All Types, Listeria Monocytogenes	Class 1	21 CFR 866.3355
GSH	Antisera, All Types, Listeria Monocytogenes	Class 1	21 CFR 866.3355	1
GSI	Antigens, Slide And Tube, All Types, Listeria Monocytogenes	Class 1	21 CFR 866.3355	1
GSJ	Antiserum, Fluorescent, Francisella Tularensis	Class 2	21 CFR 866.3280	1
GSK	Antiserum, Francisella Tularensis	Class 2	21 CFR 866.3280	1
GSL	Antigens, Slide And Tube, Francisella Tularensis	Class 2	21 CFR 866.3280	1
GSM	Antisera, Fluorescent, Brucella Spp.	Class 2	21 CFR 866.3085	4
GSN	Antiserum, Positive And Negative Febrile Antigen Control Serum	Class 2	21 CFR 866.3085	3
GSO	Antigens (Febrile), Agglutination, Brucella Spp.	Class 2	21 CFR 866.3085	12
GSP	Antiserum, Fluorescent, Campylobacter Fetus	Class 1	21 CFR 866.3110
GSQ	Antiserum, Vibrio Cholerae, All Varieties	Class 2	21 CFR 866.3930	3
GSR	Antisera, Fluorescent, Pseudomonas Pseudomallei	Class 2	21 CFR 866.3415
GSS	Antisera, Fluorescent, Pseudomonas Aeruginosa	Class 2	21 CFR 866.3415	1
GST	Antiserum, Pseudomonas Pseudomallei	Class 2	21 CFR 866.3415
GSW	Antiserum, Flavobacterium Meningosepticum, All Groups	Class 1	21 CFR 866.3270
GSX	Antisera, Acinetobacter Calcoaceticus, All Varieties	Class 1	21 CFR 866.3010
GSY	Antisera, Fluorescent, All Globulins, Proteus Spp.	Class 1	21 CFR 866.3410
GSZ	Antigens, Febrile (Weil-Felix), All Groups	Class 1	21 CFR 866.3410	3
GTA	Antisera, All, Serratia Marcesans	Class 1	21 CFR 866.3630
GTB	Antisera, Fluorescent, All Types, Klebsiella Spp.	Class 1	21 CFR 866.3340
GTC	Antisera, All Types, Klebsiella Spp.	Class 1	21 CFR 866.3340	1
GTD	Antisera, Fluorescent, All Globulins, Shigella Spp.	Class 2	21 CFR 866.3660
GTE	Antisera, Arizona Spp., All	Class 1	21 CFR 866.3035
GTF	Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.	Class 1	21 CFR 866.3125
GTH	Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae	Class 2	21 CFR 866.3390	3
GTI	Antisera, Fluorescent, All Groups, N. Meningitidis	Class 2	21 CFR 866.3390	2
GTJ	Antisera, All Groups, N. Meningitidis	Class 2	21 CFR 866.3390	16
GTL	Phages, Staphylococcal Typing, All Types	Class 1	21 CFR 866.2050
GTN	Antisera, Fluorescent, All Types, Staphylococcus Spp.	Class 1	21 CFR 866.3700	4
GTO	Anti-Streptokinase	Class 1	21 CFR 866.3720
GTP	Exoenzymes, Multiple, Streptococcal	Class 1	21 CFR 866.3720	3
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Class 1	21 CFR 866.3720	37
GTR	Antideoxyribonuclease, Streptococcus Spp.	Class 1	21 CFR 866.3720	1
GTX	Antisera, Fluorescent, All Groups, Streptococcus Spp.	Class 1	21 CFR 866.3740	2
GTY	Antigens, All Groups, Streptococcus Spp.	Class 1	21 CFR 866.3740	44
GTZ	Antisera, All Groups, Streptococcus Spp.	Class 1	21 CFR 866.3740	105
GWB	Antisera, Fluorescent, All Types, Streptococcus Pneumoniae	Class 1	21 CFR 866.3740	2
GWC	Antisera, All Types, Streptococcus Pneumoniae	Class 1	21 CFR 866.3740	9
GWD	Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp	Class 2	21 CFR 866.3220	2
JRW	Antisera, Fluorescent, B. Parapertussis	Class 1	21 CFR 866.3065	2
JRY	Antiserum, Fluorescent, Epstein-Barr Virus	Class 1	21 CFR 866.3235	9
JRZ	Media, Culture, Amino Acid Assay	Class 1	21 CFR 866.2350
JSA	Culture Media, Antibiotic Assay	Class 1	21 CFR 866.2350	8
JSB	Culture Media, Vitamin Assay	Class 1	21 CFR 866.2350
JSC	Culture Media, General Nutrient Broth	Class 1	21 CFR 866.2350	52
JSD	Culture Media, Selective Broth	Class 1	21 CFR 866.2360	26
JSE	Culture Media, Multiple Biochemical Test	Class 1	21 CFR 866.2320	53
JSF	Culture Media, Single Biochemical Test	Class 1	21 CFR 866.2320	87
JSG	Culture Media, Non-Selective And Non-Differential	Class 1	21 CFR 866.2300	209
JSH	Culture Media, Non-Selective And Differential	Class 1	21 CFR 866.2320	146
JSI	Culture Media, Selective And Differential	Class 1	21 CFR 866.2360	285
JSJ	Culture Media, Selective And Non-Differential	Class 1	21 CFR 866.2360	307
JSK	Supplement, Culture Media	Class 1	21 CFR 866.2450	70
JSL	Culture Media, Anaerobic Transport	Class 1	21 CFR 866.2390	8
JSM	Culture Media, Non-Propagating Transport	Class 1	21 CFR 866.2390	111
JSN	Culture Media, Propagating Transport	Class 1	21 CFR 866.2390	13
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hi	Class 2	21 CFR 866.1700	40
JSP	Kit, Anaerobic Identification	Class 1	21 CFR 866.2660	18
JSR	Kit, Identification, Dermatophyte	Class 1	21 CFR 866.2660	1
JSS	Kit, Identification, Enterobacteriaceae	Class 1	21 CFR 866.2660	49
JST	Kit, Fastidious Organisms	Class 1	21 CFR 866.2660	6
JSW	Kit, Identification, Glucose Nonfermenter	Class 1	21 CFR 866.2660	6