Microbiology

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Code	Device name	Class	21 CFR	510(k) (3y)
JSX	Kit, Identification, Neisseria Gonorrhoeae	Class 1	21 CFR 866.2660	16
JSY	Kit, Identification, Mycobacteria	Class 1	21 CFR 866.2660	5
JSZ	Kit, Identification, Pseudomonas	Class 1	21 CFR 866.2660	1
JTA	Monitor, Microbial Growth	Class 1	21 CFR 866.2560	11
JTB	Device, Media Dispensing/Stacking	Class 1	21 CFR 866.2440	2
JTC	Device, Microtiter Diluting/Dispensing	Class 1	21 CFR 866.2500	66
JTL	Plasma, Coagulase, Human, Horse And Rabbit	Class 1	21 CFR 866.2160	12
JTM	Anaerobic Box Glove	Class 1	21 CFR 866.2120	1
JTN	Susceptibility Test Discs, Antimicrobial	Class 2	21 CFR 866.1620	331
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Class 1	21 CFR 866.2660	244
JTQ	Bath, Incubators/Water, All	Class 1	21 CFR 866.2540	12
JTR	Kit, Quality Control For Culture Media	Class 1	21 CFR 866.2480	12
JTT	Susceptibility Test Powders, Antimicrobial	Class 2	21 CFR 866.1640	14
JTW	System, Transport, Aerobic	Class 1	21 CFR 866.2900	43
JTX	Transport Systems, Anaerobic	Class 1	21 CFR 866.2900	8
JTY	Culture Media, For Isolation Of Pathogenic Neisseria	Class 2	21 CFR 866.2410	83
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/	Class 2	21 CFR 866.1700	74
JWK	Antigen, Positive Control, Cryptococcus Neoformans	Class 2	21 CFR 866.3165	1
JWL	Antigen, Treponema Pallidum For Fta-Abs Test	Class 2	21 CFR 866.3830	4
JWT	Antigen, Cf, Aspergillus Spp.	Class 1	21 CFR 866.3040	5
JWW	Antigen, Cf, B. Dermatitidis	Class 2	21 CFR 866.3060	3
JWX	Kit, Screening, Staphylococcus Aureus	Class 1	21 CFR 866.2660	20
JWY	Manual Antimicrobial Susceptibility Test Systems	Class 2	21 CFR 866.1640	441
JWZ	Kit, Screening, Trichomonas	Class 1	21 CFR 866.2660	11
JXA	Kit, Screening, Urine	Class 1	21 CFR 866.2660	44
JXB	Kit, Identification, Yeast	Class 1	21 CFR 866.2660	16
JXC	Kit, Screening, Yeast	Class 1	21 CFR 866.2660	6
KFG	Antiserum, Positive Control, Aspergillus Spp.	Class 1	21 CFR 866.3040	5
KFH	Antiserum, Positive Control, Blastomyces Dermatitidis	Class 2	21 CFR 866.3060	4
KFI	Strip, Virulence, Corynebacterium Diphtheriae	Class 1	21 CFR 866.3140
KHW	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.	Class 2	21 CFR 866.3220	18
KLH	Antisera, C. Acnes	Class 1	21 CFR 866.3140	1
KZB	Automated Colony Counter	Class 1	21 CFR 866.2170	1
KZC	Manual Colony Counter	Class 1	21 CFR 866.2180
KZI	Culture Media, Enriched	Class 1	21 CFR 866.2330	51
KZJ	Device, Gas Generating	Class 1	21 CFR 866.2580	18
KZK	Reader, Zone, Automated	Class 1	21 CFR 866.2850	3
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Class 2	21 CFR 866.3510	94
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Class 2	21 CFR 866.3900	17
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Class 2	21 CFR 866.3175	58
LGA	Device, Oxidase Test For Gonorrhea	Class 3	21 CFR 866.2420
LGB	Gonococcal Antibody Tests	Class 3	21 CFR 866.3290
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specifi	Class 2	21 CFR 866.3305	38
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Class 2	21 CFR 866.3780	106
LHJ	Staphylococcus Aureus Protein A Insoluble	Class 1	21 CFR 866.3700	3
LHK	Antigen, Id, Candida Albicans	Class 2	21 CFR 866.3165	4
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Class 2	21 CFR 866.3300	18
LHT	Staphylococcus Aureus Somatic Antigens	Class 1	21 CFR 866.3700	13
LHW	Erythrocyte Suspension, Multi Species, Serological Reagent And Equipme	Class 1	21 CFR 866.3720	4
LIA	Antigens, All Groups, Shigella Spp.	Class 2	21 CFR 866.3660	1
LIB	Device, General Purpose, Microbiology, Diagnostic	Class 1	21 CFR 866.2660	43
LIC	Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae	Class 2	21 CFR 866.3390	9
LIE	Reagent/Device, Inoculum Calibration	Class 2	21 CFR 866.1640	7
LIN	Antisera, Conjugated Fluorescent, Cytomegalovirus	Class 2	21 CFR 866.3175	17
LIO	Device, Specimen Collection	Class 1	21 CFR 866.2900	63
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Class 2	21 CFR 866.3830	35
LIQ	Enzyme Linked Immunoabsorbent Assay, Rotavirus	Class 1	21 CFR 866.3405	33
LIR	Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae	Class 2	21 CFR 866.3390	3
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Class 1	21 CFR 866.3520	11
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	Class 1	21 CFR 866.3120	67
LJF	Device, Antimicrobial Drug Removal	Class 1	21 CFR 866.2560	4
LJG	Quality Control Slides	Class 1	21 CFR 866.2660	27
LJK	Antisera, If, Toxoplasma Gondii	Class 2	21 CFR 866.3780	6
LJN	Antibody Igm, If, Epstein-Barr Virus	Class 1	21 CFR 866.3235	23
LJO	Antigen, Iha, Cytomegalovirus	Class 2	21 CFR 866.3175	12
LJP	Antiserum, Fluorescent, Chlamydia Trachomatis	Class 1	21 CFR 866.3120	35
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Class 1	21 CFR 866.3380	8
LJZ	Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	Class 1	21 CFR 866.3375	13
LKA	Culture Media, Antimicrobial Susceptibility Test	Class 2	21 CFR 866.1700	5
LKC	Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus	Class 2	21 CFR 866.3305
LKH	Antisera, Immunoperoxidase, Chlamydia Spp.	Class 1	21 CFR 866.3120	8
LKI	Antisera, Fluorescent, Chlamydia Spp.	Class 1	21 CFR 866.3120	6
LKQ	Antibody Igm,If, Cytomegalovirus Virus	Class 2	21 CFR 866.3175	18
LKS	Device, Parasite Concentration	Class 1	21 CFR 866.2900	13
LKT	Respiratory Syncytial Virus, Antigen, Antibody, Ifa	Class 1	21 CFR 866.3480	23
LLA	Direct Agglutination Test, Toxoplasma Gondii	Class 2	21 CFR 866.3780	4
LLH	Reagents, Clostridium Difficile Toxin	Class 1	21 CFR 866.2660	42
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Class 1	21 CFR 866.3235	27
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Class 2	21 CFR 866.3310	26
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Class 2	21 CFR 866.3172	1
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubatio	Class 2	21 CFR 866.1645	289
LOO	Reagent, Leishmanii Serological	Class 1	21 CFR 866.3870	2
LOP	Solution, Antimicrobial	Class 2	21 CFR 866.1640	3
LQF	Dna-Reagents, Mycobacterium Spp.	Class 1	21 CFR 866.3370	15
LQG	Dna-Reagents, Mycoplasma Spp.	Class 1	21 CFR 866.3375	1
LQH	Dna-Reagents, Legionella	Class 2	21 CFR 866.3300	2
LQL	Gram Positive Identification Panel	Class 1	21 CFR 866.2660	11
LQM	Gram Negative Identification Panel	Class 1	21 CFR 866.2660	7
LQN	Latex Agglutination Assay, Rubella	Class 2	21 CFR 866.3510	13
LQO	Dna-Reagents, Campylobacter Spp.	Class 1	21 CFR 866.3110	4
LQP	Campylobacter Spp.	Class 1	21 CFR 866.3110	12
LRF	Candida Spp., Direct Antigen, Id	Class 2	21 CFR 866.3165	3
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Syst	Class 2	21 CFR 866.1640	45
LRH	Instrument For Auto Reader Of Overnight Microorganism Identification S	Class 1	21 CFR 866.2660	4
LSC	Neisseria Controls	Class 1	21 CFR 866.2660	7
LSD	Rubella, Other Assays	Class 2	21 CFR 866.3510
LSE	Epstein-Barr Virus, Other	Class 1	21 CFR 866.3235	56
LSF	Dna-Reagents, Epstein-Barr Virus	Class 1	21 CFR 866.3235
LSG	Candida Species, Antibody Detection	Class 2	21 CFR 866.3165
LSH	Antigen, Blastomyces Dermatitidis, Other	Class 2	21 CFR 866.3060
LSI	Antiserum, Blastomyces Dermatitidis, Other	Class 2	21 CFR 866.3060
LSJ	Antigen, Rubella, Other	Class 2	21 CFR 866.3510
LSK	Dna-Reagents, Chlamydia	Class 1	21 CFR 866.3120	8
LSL	Dna-Reagents, Neisseria	Class 2	21 CFR 866.3390	45
LSM	Dna-Reagents, Salmonella Spp.	Class 2	21 CFR 866.3550
LSN	Dna-Reagents, Shigella Spp.	Class 2	21 CFR 866.3660
LSO	Dna-Reagents, Cytomegalovirus	Class 2	21 CFR 866.3175
LSQ	Reagent, Rickettsia Serological	Class 1	21 CFR 866.3500	4
LSR	Reagent, Borrelia Serological Reagent	Class 2	21 CFR 866.3830	112
LTS	Test Reagents, Neisseria Gonorrhoeae Biochemical	Class 1	21 CFR 866.2660	1
LTT	Panels, Test, Susceptibility, Antimicrobial	Class 2	21 CFR 866.1640	50
LTW	Susceptibility Test Cards, Antimicrobial	Class 2	21 CFR 866.1640	16
LTX	Discs, Elution	Class 2	21 CFR 866.1620	2
LYF	Pneumocystis Carinii	Class 2	21 CFR 866.3780	7
LYR	Helicobacter Pylori	Class 1	21 CFR 866.3110	91
MBT	Dna-Probe, Reagent, Histoplasma Capsulatum	Class 2	21 CFR 866.3320	1
MCB	Antigen, C. Difficile	Class 1	21 CFR 866.2660	10
MCC	Dna-Probe, Haemophilus Spp.	Class 2	21 CFR 866.3300	2
MCD	Antigen, Ebv, Capsid	Class 1	21 CFR 866.3235	8
MCE	Respiratory Syncytial Virus - Elisa	Class 1	21 CFR 866.3480	2
MCG	Dna-Probe, Agent, Listeria	Class 1	21 CFR 866.3355
MCS	Dna-Probe, Staphylococcus Aureus	Class 1	21 CFR 866.3700	1
MCT	Dna-Probe, Strep Pneumoniae	Class 1	21 CFR 866.3740	1
MDB	System, Blood Culturing	Class 1	21 CFR 866.2560	68
MDC	Dna-Probe - Blastomyces Dermatitidis	Class 2	21 CFR 866.3060	1
MDE	Dna-Probe, Reagents, Cryptococcal	Class 2	21 CFR 866.3165	1
MDF	Dna-Probe, Reagents, Coccidioides Immitis	Class 2	21 CFR 866.3135	1
MDJ	Reagents, Cysticercosis	Class 1	21 CFR 866.3200	1
MDK	Dna-Probe, Reagents, Streptococcal	Class 1	21 CFR 866.3740	4
MDT	Elisa, Trichinella Spiralis	Class 1	21 CFR 866.3850
MDU	Antigen, Elisa, Cryptococcus	Class 2	21 CFR 866.3165	2
MGM	C. Trachomatis (Chlamydia Group)	Class 1	21 CFR 866.3120
MHI	Giardia Spp.	Class 2	21 CFR 866.3220	27
MHJ	Cryptosporidium Spp.	Class 2	21 CFR 866.3220	15
MIU	Enzyme Linked Immunosorbent Assay, T. Cruzi	Class 1	21 CFR 866.3870	6
MIV	Immunofluorescent Assay, T. Cruzi	Class 1	21 CFR 866.3870
MIY	Enzyme Linked Immunosorbent Assay, Coccidioides Immitis	Class 2	21 CFR 866.3135	1
MIZ	Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum	Class 2	21 CFR 866.3320	2
MJA	Susceptibility Test Powders, Antimycobacterial	Class 2	21 CFR 866.1640	5
MJD	Culture Media, Antimycobacteria, Susceptibility Test	Class 2	21 CFR 866.1700	3
MJE	Culture Media, Antifungal, Susceptibility Test	Class 2	21 CFR 866.1700	1
MJH	Legionella, Spp., Elisa	Class 2	21 CFR 866.3300	10
MJK	Dna Probe, Trichomonas Vaginalis	Class 1	21 CFR 866.2660	1
MJL	Eia, Blastomyces Dermatitidis	Class 2	21 CFR 866.3060	2
MJM	Dna Probe, Gardnerella Vaginalis	Class 1	21 CFR 866.2660	2
MKT	Hepatitis Viral B Dna Detection	Class 2	21 CFR 866.3174
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Class 1	21 CFR 866.3120	19
MLA	Dna Probe, Yeast	Class 1	21 CFR 866.2660	2
MSQ	Test, Urea (Breath Or Blood)	Class 1	21 CFR 866.3110	17
MWA	System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex	Class 2	21 CFR 866.3372
MXB	Test, Vaginal, Bacterial Sialidase	Class 1	21 CFR 866.2660	2
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Class 2	21 CFR 866.3305	20
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Class 2	21 CFR 866.3305	10
MYI	System, Test, Genotypic Detection, Resistant Markers, Staphylococcus C	Class 2	21 CFR 866.1640	10
MYR	Test, Donor, Syphilis, Antigens, Treponemal	Class 2	21 CFR 866.3830
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Class 1	21 CFR 866.2560
MZF	Test, Hiv Detection	Class 2	21 CFR 866.3956
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Class 2	21 CFR 866.3169	2
MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection O	Class 2	21 CFR 866.3170	4
NDZ	Assay, Nucleic Acid Amplification, Growth Identification, Mycobacteriu	Class 1	21 CFR 866.3370	1
NGS	Assay, Endotoxin Activity, Chemiluminescent	Class 2	21 CFR 866.3210	2
NGZ	Susceptibility Test Plate, Antifungal	Class 2	21 CFR 866.1640	21
NHT	Assay, Nucleic Acid Amplification, Bacillus Anthracis	Class 2	21 CFR 866.3045	6
NHY	Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus	Class 1	21 CFR 866.3480
NHZ	Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus	Class 1	21 CFR 866.3400
NIA	Assay, Direct, Nucleic Acid Amplification, Influenza Virus	Class 1	21 CFR 866.3330
NIJ	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Spe	Class 2	21 CFR 866.1640	6
NJO	System, Mycolic Acid Analysis, Mycobacterium Tuberculosis	Class 1	21 CFR 866.3370	1
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct	Class 1	21 CFR 866.3740	18
NOM	Antigen, Galactomannan, Aspergillus Spp.	Class 1	21 CFR 866.3040	4
NOP	Elisa, Antibody, West Nile Virus	Class 2	21 CFR 866.3940	10
NPO	Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody	Class 2	21 CFR 866.3045	1
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant St	Class 2	21 CFR 866.1640	24
NQZ	Antigen, Invasive Fungal Pathogens	Class 2	21 CFR 866.3050	2
NRL	Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis	Class 2	21 CFR 866.3045	1
NTM	Antigen, Inflammatory Response Marker, Sepsis	Class 2	21 CFR 866.3210	3
NVQ	Bacteriophage And Controls, B. Anthracis Lysis	Class 2	21 CFR 866.3045	2
NWZ	Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids	Class 2	21 CFR 866.3045	1
NXD	Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Linea	Class 2	21 CFR 866.3332	3
NXX	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rn	Class 1	21 CFR 866.3700	4
NZB	Quality Control Material, Genetics, Dna	Class 2	21 CFR 866.5910	4
NZS	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rn	Class 1	21 CFR 866.2660	3
OAH	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, En	Class 1	21 CFR 866.3740	4
OAI	Assay, Enterovirus Nucleic Acid	Class 2	21 CFR 866.3225	2
OAX	Plasmodium Spp. Detection Reagents	Class 2	21 CFR 866.3402	1
OBF	Assay, Genotyping, Hepatitis C Virus	Class 2	21 CFR 866.3170
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Class 2	21 CFR 866.3980	79
OEH	Joint Biological Agent Identification And Diagnostic System (Jbaids) T	Class 2	21 CFR 866.3280	2
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Class 2	21 CFR 866.3980	6
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay	Class 2	21 CFR 866.3980	1
OID	Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Exclude	Class 1	21 CFR 866.2900
OJY	Device To Detect Or Measure Nucleic Acid From Viruses Associated With	Class 2	21 CFR 866.3236	1
OMG	Antisera, Fluorescent, Human Metapneumovirus	Class 2	21 CFR 866.3980	4
OMI	Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv	Class 2	21 CFR 866.3510	2
OMN	C. Difficile Nucleic Acid Amplification Test Assay	Class 1	21 CFR 866.2660	5
OMS	Novel Influenza A Virus, A/H5 Ns1 Protein	Class 2	21 CFR 866.3332	1
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Class 2	21 CFR 866.3980	5
OPL	Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Vari	Class 2	21 CFR 866.3510	3
OPM	Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herp	Class 2	21 CFR 866.3510	1
OQO	Herpes Simplex Virus Nucleic Acid Amplification Assay	Class 2	21 CFR 866.3305	12