FDA Device Explorer

Microbiology (MI) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the Microbiology (MI) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 610, Part 866

Subparts

Product Codes

Product CodeDevice NameRegulationClassDevices
QHMSerology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations610.40U0
QHONucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations610.40U0
JTNSusceptibility Test Discs, Antimicrobial866.16202328
LTXDiscs, Elution866.162022
JTTSusceptibility Test Powders, Antimicrobial866.1640224
JWYManual Antimicrobial Susceptibility Test Systems866.16402441
LIEReagent/Device, Inoculum Calibration866.164027
LOPSolution, Antimicrobial866.164023
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems866.1640245
LTTPanels, Test, Susceptibility, Antimicrobial866.1640252
LTWSusceptibility Test Cards, Antimicrobial866.1640217
MJASusceptibility Test Powders, Antimycobacterial866.164025
MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies866.1640210
NGZSusceptibility Test Plate, Antifungal866.1640221
NIJSystem, Test, Genotypic Detection, Resistant Markers, Enterococcus Species866.164026
NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen866.1640224
PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony866.164023
POCSystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen866.164023
PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates866.164023
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation866.16452301
PRHPositive Blood Culture Identification And Ast Kit866.165022
QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing866.165023
SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples866.165026
QIVCulture-Based Short-Term Incubation Antimicrobial Resistance Assay866.165521
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar866.1700240
JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth866.1700274
LKACulture Media, Antimicrobial Susceptibility Test866.170025
MJDCulture Media, Antimycobacteria, Susceptibility Test866.170023
MJECulture Media, Antifungal, Susceptibility Test866.170021
GTLPhages, Staphylococcal Typing, All Types866.205010
OUSMethicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt866.205012
JTMAnaerobic Box Glove866.212011
JTLPlasma, Coagulase, Human, Horse And Rabbit866.2160112
KZBAutomated Colony Counter866.217011
KZCManual Colony Counter866.218010
PPUMicrobial Colony Image Assessment System866.219023
QQYCulture Plate Imaging System For Qualitative Assessment Of Resistant Organisms866.219022
JSGCulture Media, Non-Selective And Non-Differential866.23001209
JSECulture Media, Multiple Biochemical Test866.2320153
JSFCulture Media, Single Biochemical Test866.2320187
JSHCulture Media, Non-Selective And Differential866.23201146
KZICulture Media, Enriched866.2330151
JRZMedia, Culture, Amino Acid Assay866.235010
JSACulture Media, Antibiotic Assay866.235018
JSBCulture Media, Vitamin Assay866.235010
JSCCulture Media, General Nutrient Broth866.2350152
JSDCulture Media, Selective Broth866.2360126
JSICulture Media, Selective And Differential866.23601285
JSJCulture Media, Selective And Non-Differential866.23601307
PQZGbs Culture Media, Selective And Differential866.236014
JSLCulture Media, Anaerobic Transport866.239018
JSMCulture Media, Non-Propagating Transport866.23901111
JSNCulture Media, Propagating Transport866.2390113
QMCTransport Medium, Notified Per The Vtm Guidance866.239010
JTYCulture Media, For Isolation Of Pathogenic Neisseria866.2410283
LGADevice, Oxidase Test For Gonorrhea866.242030
JTBDevice, Media Dispensing/Stacking866.244012
JSKSupplement, Culture Media866.2450170
JTRKit, Quality Control For Culture Media866.2480112
JTCDevice, Microtiter Diluting/Dispensing866.2500166
JTQBath, Incubators/Water, All866.2540112
JTAMonitor, Microbial Growth866.2560111
LJFDevice, Antimicrobial Drug Removal866.256014
MDBSystem, Blood Culturing866.2560167
MZCSystem, Detection, Bacterial, For Platelet Transfusion Products866.256010
QBQSystem, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture866.256011
KZJDevice, Gas Generating866.2580118
GMBLight, Wood'S, Fluorescence866.260010
JSPKit, Anaerobic Identification866.2660118
JSRKit, Identification, Dermatophyte866.266011
JSSKit, Identification, Enterobacteriaceae866.2660149
JSTKit, Fastidious Organisms866.266016
JSWKit, Identification, Glucose Nonfermenter866.266016
JSXKit, Identification, Neisseria Gonorrhoeae866.2660117
JSYKit, Identification, Mycobacteria866.266015
JSZKit, Identification, Pseudomonas866.266011
JTODiscs, Strips And Reagents, Microorganism Differentiation866.26601244
JWXKit, Screening, Staphylococcus Aureus866.2660120
JWZKit, Screening, Trichomonas866.2660111
JXAKit, Screening, Urine866.2660144
JXBKit, Identification, Yeast866.2660116
JXCKit, Screening, Yeast866.266016
LIBDevice, General Purpose, Microbiology, Diagnostic866.2660143
LJGQuality Control Slides866.2660127
LLHReagents, Clostridium Difficile Toxin866.2660142
LQLGram Positive Identification Panel866.2660111
LQMGram Negative Identification Panel866.266017
LRHInstrument For Auto Reader Of Overnight Microorganism Identification System866.266014
LSCNeisseria Controls866.266017
LTSTest Reagents, Neisseria Gonorrhoeae Biochemical866.266011
MCBAntigen, C. Difficile866.2660110
MJKDna Probe, Trichomonas Vaginalis866.266011
MJMDna Probe, Gardnerella Vaginalis866.266012
MLADna Probe, Yeast866.266012
MXBTest, Vaginal, Bacterial Sialidase866.266012
NZSFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast866.266013
OMNC. Difficile Nucleic Acid Amplification Test Assay866.266015
PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System866.2680213
KZKReader, Zone, Automated866.285013
JTWSystem, Transport, Aerobic866.2900143
JTXTransport Systems, Anaerobic866.290018
LIODevice, Specimen Collection866.2900163
LKSDevice, Parasite Concentration866.2900113
OIDSex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)866.290010
SEPDevice For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay866.292022
QBDMicrobial Nucleic Acid Storage And Stabilization Device866.2950217
GSXAntisera, Acinetobacter Calcoaceticus, All Varieties866.301010
GNYAntisera, Fluorescent, Adenovirus 1-33866.302014
GNZAntisera, Neutralization, Adenovirus 1-33866.302010
GOAAntisera, Cf, Adenovirus 1-33866.302011
GOBAntigens, Ha (Including Ha Control), Adenovirus 1-33866.302011
GOCAntisera, Hai, Adenovirus 1-33866.302010
GODAntigens, Cf (Including Cf Control), Adenovirus 1-33866.3020111
GTEAntisera, Arizona Spp., All866.303510
JWTAntigen, Cf, Aspergillus Spp.866.304015
KFGAntiserum, Positive Control, Aspergillus Spp.866.304015
NOMAntigen, Galactomannan, Aspergillus Spp.866.304014
NHTAssay, Nucleic Acid Amplification, Bacillus Anthracis866.304526
NPOKit, Immunochromatographic, Bacillus Anthracis Differential Antibody866.304521
NRLEnzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis866.304521
NVQBacteriophage And Controls, B. Anthracis Lysis866.304522
NWZGas Chromatography, Bacillus Anthracis Membrane Fatty Acids866.304521
QUUSimple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples866.304622
NQZAntigen, Invasive Fungal Pathogens866.305022
JWWAntigen, Cf, B. Dermatitidis866.306023
KFHAntiserum, Positive Control, Blastomyces Dermatitidis866.306024
LSHAntigen, Blastomyces Dermatitidis, Other866.306020
LSIAntiserum, Blastomyces Dermatitidis, Other866.306020
MDCDna-Probe - Blastomyces Dermatitidis866.306021
MJLEia, Blastomyces Dermatitidis866.306022
GOTAntigen, B. Parapertussis866.306510
GOWAntisera, Agglutinating, B. Parapertussis866.306510
GOXAntigen, B. Pertussis866.306511
GOYAntisera, Agglutinating, B. Pertussis, All866.306511
GOZAntisera, Fluorescent, B. Pertussis866.306510
JRWAntisera, Fluorescent, B. Parapertussis866.306512
GSMAntisera, Fluorescent, Brucella Spp.866.308524
GSNAntiserum, Positive And Negative Febrile Antigen Control Serum866.308523
GSOAntigens (Febrile), Agglutination, Brucella Spp.866.3085212
GSPAntiserum, Fluorescent, Campylobacter Fetus866.311010
LQODna-Reagents, Campylobacter Spp.866.311014
LQPCampylobacter Spp.866.3110112
LYRHelicobacter Pylori866.3110191
MSQTest, Urea (Breath Or Blood)866.3110117
OWFImmunohistochemical Assay, Helicobacter Pylori866.311011
OZATest, Urea Adult And Pediatric (Breath),866.311032
GPTAntiserum, Cf, Psittacosis (Chlamydia Group)866.312011
GPWAntigen, Cf, Psittacosis (Chlamydia Group)866.312014
LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)866.3120167
LJPAntiserum, Fluorescent, Chlamydia Trachomatis866.3120135
LKHAntisera, Immunoperoxidase, Chlamydia Spp.866.312018
LKIAntisera, Fluorescent, Chlamydia Spp.866.312016
LSKDna-Reagents, Chlamydia866.312018
MGMC. Trachomatis (Chlamydia Group)866.312010
MKZDna Probe, Nucleic Acid Amplification, Chlamydia866.3120119
GTFAntisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.866.312510
OZNC. Difficile Toxin Gene Amplification Assay866.3130217
GMGAntigen, Latex Agglutination, Coccidioides Immitis866.313525
GMHAntiserum, Positive Control, Coccidioides Immitis866.313525
GMIAntigen, Cf And / Or Id, Coccidioides Immitis866.3135211
MDFDna-Probe, Reagents, Coccidioides Immitis866.313521
MIYEnzyme Linked Immunosorbent Assay, Coccidioides Immitis866.313521
GOPAntisera, C. Acnes (553, 605)866.314010
GOSAntiserum, Fluorescent, C. Diphtheriae866.314010
KFIStrip, Virulence, Corynebacterium Diphtheriae866.314010
KLHAntisera, C. Acnes866.314011
GNGAntigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6866.314512
GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6866.314519
GNNAntisera, Neutralization, Coxsackievirus A 1-24, B 1-6866.314511
GNOAntisera, Cf, Coxsackievirus A 1-24, B 1-6866.314511
GMDAntisera, Latex Agglutination, Cryptococcus Neoformans866.3165210
GMEAntisera, Fluorescent, Cryptococcus Neoformans866.316520
JWKAntigen, Positive Control, Cryptococcus Neoformans866.316521
LHKAntigen, Id, Candida Albicans866.316524
LRFCandida Spp., Direct Antigen, Id866.316523
LSGCandida Species, Antibody Detection866.316520
MDEDna-Probe, Reagents, Cryptococcal866.316521
MDUAntigen, Elisa, Cryptococcus866.316522
MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus866.3169211
MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus866.3170213
OBFAssay, Genotyping, Hepatitis C Virus866.317022
SBPSimple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test866.317121
LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)866.3172225
SEIQualitative And Quantitative Hepatitis B Virus Antibody Assays866.3173234
MKTHepatitis Viral B Dna Detection866.317425
GQHAntigen, Cf (Including Cf Control), Cytomegalovirus866.3175219
GQIAntiserum, Cf, Cytomegalovirus866.3175218
LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus866.3175258
LINAntisera, Conjugated Fluorescent, Cytomegalovirus866.3175217
LJOAntigen, Iha, Cytomegalovirus866.3175212
LKQAntibody Igm,If, Cytomegalovirus Virus866.3175218
LSODna-Reagents, Cytomegalovirus866.317520
PABCytomegalovirus (Cmv) Dna Quantitative Assay866.318029
QDZQualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection866.318122
QLXNucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna866.318324
QMINucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna866.318322
GPDAntigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus866.320010
GPEAntisera, Positive Control, Echinococcus Spp.866.320010
GPFAntigen, Agglutinating, Echinococcus Spp.866.320011
MDJReagents, Cysticercosis866.320011
GNIAntisera, Neutralization, Echovirus 1-34866.320510
GNJAntigens, Ha, Echovirus 1-34866.320511
GNKAntisera, Cf, Echovirus 1-34866.320513
GNLAntigens, Cf (Including Cf Control), Echovirus 1-34866.320512
GRKAntisera, Fluorescent, Echovirus 1-34866.320510
NGSAssay, Endotoxin Activity, Chemiluminescent866.321022
NTMAntigen, Inflammatory Response Marker, Sepsis866.321023
PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens866.321525
PRERt-Qpcr Assay For Mrna Transcript Immune Biomarkers866.321524
PRIProcalcitonin Assay866.321528
PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission866.321524
QFSMonocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment866.321521
QPSImmunoassay For Host Biomarkers Of Infection866.321524
QUTDeformability Cytometry For Sepsis Risk Assessment866.321523
SCXImmunoassay For Host Biomarkers Of Sepsis866.321521
GMOAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.866.322020
GWDIndirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp866.322022
KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.866.3220218
MHIGiardia Spp.866.3220227
MHJCryptosporidium Spp.866.3220215
OAIAssay, Enterovirus Nucleic Acid866.322522
QGNLateral Flow Immunochromatography Assay For Host Infection Biomarkers866.323022
QXALateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection866.323022
QFAAssay For Detection Of Proteases In Chronic Wounds866.323121
GNPAntiserum, Cf, Epstein-Barr Virus866.3235120
GNQAntigen, Cf (Including Cf Control), Epstein-Barr Virus866.323510
JRYAntiserum, Fluorescent, Epstein-Barr Virus866.323519
LJNAntibody Igm, If, Epstein-Barr Virus866.3235123
LLMTest, Antigen, Nuclear, Epstein-Barr Virus866.3235127
LSEEpstein-Barr Virus, Other866.3235156
LSFDna-Reagents, Epstein-Barr Virus866.323510
MCDAntigen, Ebv, Capsid866.323518
OJYDevice To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers866.323621
GQCAntisera, Cf, Equine Encephalitis Virus, Eee, Wee866.324012
GQDAntigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee866.324010
GSDAntiserum, Fluorescent, Erysipelothrix Rhusiopathiae866.325010
GSEAntiserum, Erysipelothrix Rhusiopathiae866.325010
GSFAntigen, Erysipelothrix Rhusiopathiae866.325010
GMYAntisera, Fluorescent, All Types, Escherichia Coli866.325512
GMZAntigens, All Types, Escherichia Coli866.3255114
GNAAntisera, All Types, Escherichia Coli866.3255112
GSWAntiserum, Flavobacterium Meningosepticum, All Groups866.327010
GSJAntiserum, Fluorescent, Francisella Tularensis866.328021
GSKAntiserum, Francisella Tularensis866.328021
GSLAntigens, Slide And Tube, Francisella Tularensis866.328021
OEHJoint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit866.328022
LGBGonococcal Antibody Tests866.329031
GROAntisera, Fluorescent, All Types, Hemophilus Spp.866.330024
GRPAntisera, All Types, H. Influenza866.330026
LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent866.3300218
LQHDna-Reagents, Legionella866.330022
MCCDna-Probe, Haemophilus Spp.866.330022
MJHLegionella, Spp., Elisa866.3300210
GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2866.3305237
GQMAntisera, Neutralization, Herpesvirus Hominis866.330523
GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2866.3305234
GQOAntisera, Cf, Herpesvirus Hominis 1,2866.3305216
LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific866.3305238
LKCAntigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus866.330520
MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1866.3305220
MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2866.3305210
OQOHerpes Simplex Virus Nucleic Acid Amplification Assay866.3305212
PGHHsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel866.330723
PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples866.330929
LOLHepatitis A Test (Antibody And Igm Antibody)866.3310233
PBKNon-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set866.331525
PRAVariola Virus Nucleic Acid-Based Detection Assay866.331621
PVQRickettsia Spp. Nucleic Acid Based Detection Assay866.331621
GMJAntigens, Histoplasma Capsulatum, All866.3320212
GMKAntiserum, Positive Control, Histoplasma Capsulatum866.332029
GMLAntisera, Fluorescent, Histoplasma Capsulatum866.332020
MBTDna-Probe, Reagent, Histoplasma Capsulatum866.332021
MIZEnzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum866.332022
PSZDevices Detecting Influenza A, B, And C Virus Antigens866.3328272
GNRAntisera, Neutralization, Influenza Virus A, B, C866.333011
GNSAntisera, Hai, Influenza Virus A, B, C866.333019
GNTAntigens, Ha (Including Ha Control), Influenza Virus A, B, C866.333015
GNWAntisera, Cf, Influenza Virus A, B, C866.3330116
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C866.3330118
NIAAssay, Direct, Nucleic Acid Amplification, Influenza Virus866.333010
NXDNucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna866.333223
OMSNovel Influenza A Virus, A/H5 Ns1 Protein866.333221
OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification866.3332210
OYPAnti-Jcv Antibody Detection Assay866.333622
GTBAntisera, Fluorescent, All Types, Klebsiella Spp.866.334010
GTCAntisera, All Types, Klebsiella Spp.866.334011
GRWAntisera, All Fluorescent, Leptospira Spp.866.335020
GRXAntisera, All Leptospira Spp.866.335020
GRYAntigens, All, Leptospira Spp.866.335022
GSGAntisera, Fluorescent, All Types, Listeria Monocytogenes866.335510
GSHAntisera, All Types, Listeria Monocytogenes866.335511
GSIAntigens, Slide And Tube, All Types, Listeria Monocytogenes866.335511
MCGDna-Probe, Agent, Listeria866.335510
GQJAntiserum, Cf, Lymphocytic Choriomeningitis Virus866.336010
GQKAntigen, Cf, Lymphocytic Choriomeningitis Virus866.336010
PEXSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates866.336125
PAMGram-Positive Bacteria And Their Resistance Markers866.336526
PENGram-Negative Bacteria And Associated Resistance Markers866.3365211
PEOFungal Organisms, Nucleic Acid-Based Assay866.336522
PYNFish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.866.336721
GRTAntiserum, Fluorescent, Mycobacterium Tuberculosis866.337011
LQFDna-Reagents, Mycobacterium Spp.866.3370115
NDZAssay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis866.337011
NJOSystem, Mycolic Acid Analysis, Mycobacterium Tuberculosis866.337011
MWASystem, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex866.337222
PEUSystem, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen866.337322
GRZAntisera, Fluorescent, All, Mycoplasma Spp.866.337515
GSAAntisera, All Mycoplasma Spp.866.337516
GSBAntigens, Cf, All, Mycoplasma Spp.866.337515
LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.866.3375113
LQGDna-Reagents, Mycoplasma Spp.866.337511
QAACoccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens866.337621
QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates866.337824
QNJMass Spectrometry, Microorganism Identification, Blood Culture866.337822
QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry866.337824
GQYAntigen, Ha (Including Ha Control), Mumps Virus866.338010
GQZAntiserum, Neutralization, Mumps Virus866.338010
GRAAntiserum, Fluorescent, Mumps Virus866.338013
GRBAntiserum, Cf, Mumps Virus866.338012
GRCAntigen, Cf (Including Cf Control), Mumps Virus866.338013
GRDAntiserum, Hai, Mumps Virus866.338011
LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus866.338018
QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home866.338522
SEATest For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users866.338621
GTHAntiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae866.339023
GTIAntisera, Fluorescent, All Groups, N. Meningitidis866.339022
GTJAntisera, All Groups, N. Meningitidis866.3390216
LICAntiserum, Coagglutination (Direct) Neisseria Gonorrhoeae866.339029
LIRAntigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae866.339023
LSLDna-Reagents, Neisseria866.3390245
QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections866.3393221
OUCNorovirus Serological Reagent866.339521
GQPAntisera, Neutralization, Parainfluenza Virus 1-4866.340012
GQQAntisera, Hai, Parainfluenza Virus 1-4866.340011
GQRAntigens, Ha (Including Ha Control), Parainfluenza Virus 1-4866.340011
GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-4866.3400111
GQTAntisera, Cf, Parainfluenza Virus 1-4866.340014
NHZAssay, Direct, Nucleic Acid Amplification, Parainfluenza Virus866.340010
OAXPlasmodium Spp. Detection Reagents866.340221
GOEAntisera, Fluorescent, Poliovirus 1-3866.340517
GOFAntisera, Neutralization, Poliovirus 1-3866.340510
GOGAntisera, Cf, Poliovirus 1-3866.340513
GOHAntigens, Cf (Including Cf Control), Poliovirus 1-3866.340510
LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus866.3405133
GSYAntisera, Fluorescent, All Globulins, Proteus Spp.866.341010
GSZAntigens, Febrile (Weil-Felix), All Groups866.341013
GSRAntisera, Fluorescent, Pseudomonas Pseudomallei866.341520
GSSAntisera, Fluorescent, Pseudomonas Aeruginosa866.341521
GSTAntiserum, Pseudomonas Pseudomallei866.341520
GOIAntiserum, Fluorescent, Rabies Virus866.346022
GPXAntisera, Neutralizion, Reovirus 1-3866.347010
GPYAntisera, Hai, Reovirus 1-3866.347010
GPZAntisera, Cf, Reovirus 1-3866.347010
GQAAntigens, Ha (Including Ha Control), Reovirus 1-3866.347010
GQBAntigens, Cf (Including Cf Control), Reovirus 1-3866.347010
GQFAntiserum, Neutralization, Respiratory Syncytial Virus866.348010
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus866.3480132
LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa866.3480123
MCERespiratory Syncytial Virus - Elisa866.348012
NHYAssay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus866.348010
GQEAntisera, Neutralization, All Types, Rhinovirus866.349010
GPJAntiserum, Fluorescent, Q Fever866.350012
GPKAntiserum, Rickettsial Pox866.350010
GPMAntiserum, Murine Typhus Fever866.350011
GPNAntiserum, Typhus Fever866.350011
GPOAntigen, Cf, Typhus Fever Group866.350011
GPPAntiserum, Rocky Mountain Spotted Fever866.350011
GPQAntigen, Cf, Spotted Fever Group866.350010
GPRAntiserum, Cf, Q Fever866.350010
GPSAntigen, Cf, Q Fever866.350011
LSQReagent, Rickettsia Serological866.350014
OVFAssay, Direct, Nucleic Acid Amplification, Q Fever866.350011
GOJAntisera, Neutralization, Rubella866.351020
GOKAntisera, Hai (Including Hai Control), Rubella866.3510211
GOLAntigen, Ha (Including Ha Control), Rubella866.3510221
GOMAntisera, Cf, Rubella866.351022
GONAntigen, Cf (Including Cf Control), Rubella866.351025
LFXEnzyme Linked Immunoabsorbent Assay, Rubella866.3510294
LQNLatex Agglutination Assay, Rubella866.3510213
LSDRubella, Other Assays866.351020
LSJAntigen, Rubella, Other866.351020
OMIMultiplex Flow Immunoassay, T. Gondii, Rubella And Cmv866.351022
OPLMultiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus866.351023
OPMMultiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2866.351021
PUQMultiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm866.351021
GREAntiserum, Fluorescent, Rubeola866.352014
GRFAntiserum, Cf, Rubeola866.352012
GRGAntiserum, Hai, Rubeola866.352010
GRHAntigen, Ha (Including Ha Control), Rubeola866.352010
GRIAntiserum, Neutralization, Rubeola866.352010
GRJAntigen, Cf, (Including Cf Control), Rubeola866.352012
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg866.3520111
PCLEnzyme Linked Immunoabsorbent Assay, Rubeola Igm866.352011
GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.866.3550260
GOOAntisera, Fluorescent, All Globulins, Salmonella Spp.866.355020
GRLAntigens, All Groups, Salmonella Spp.866.355022
GRMAntisera, All Groups, Salmonella Spp.866.3550269
LSMDna-Reagents, Salmonella Spp.866.355020
GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni866.360012
GTAAntisera, All, Serratia Marcesans866.363010
GNBAntisera, All Types, Shigella Spp.866.3660241
GTDAntisera, Fluorescent, All Globulins, Shigella Spp.866.366020
LIAAntigens, All Groups, Shigella Spp.866.366021
LSNDna-Reagents, Shigella Spp.866.366020
GMAAntisera, Fluorescent, Sporothrix Schenekii866.368011
GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.866.370014
LHJStaphylococcus Aureus Protein A Insoluble866.370013
LHTStaphylococcus Aureus Somatic Antigens866.3700113
MCSDna-Probe, Staphylococcus Aureus866.370011
NXXFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus866.370014
GTOAnti-Streptokinase866.372010
GTPExoenzymes, Multiple, Streptococcal866.372013
GTQAntistreptolysin - Titer/Streptolysin O Reagent866.3720137
GTRAntideoxyribonuclease, Streptococcus Spp.866.372011
LHWErythrocyte Suspension, Multi Species, Serological Reagent And Equipment866.372014
GTXAntisera, Fluorescent, All Groups, Streptococcus Spp.866.374012
GTYAntigens, All Groups, Streptococcus Spp.866.3740143
GTZAntisera, All Groups, Streptococcus Spp.866.37401105
GWBAntisera, Fluorescent, All Types, Streptococcus Pneumoniae866.374012
GWCAntisera, All Types, Streptococcus Pneumoniae866.374019
MCTDna-Probe, Strep Pneumoniae866.374011
MDKDna-Probe, Reagents, Streptococcal866.374014
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test866.3740118
OAHFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis866.374014
OYZGroup A Streptococcus Nucleic Acid Amplification Assay System866.374011
GLZAntigens, If, Toxoplasma Gondii866.3780218
GMMAntigens, Iha, Toxoplasma Gondii866.378028
GMNAntigens, Cf, Toxoplasma Gondii866.378023
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii866.37802106
LJKAntisera, If, Toxoplasma Gondii866.378026
LLADirect Agglutination Test, Toxoplasma Gondii866.378024
LYFPneumocystis Carinii866.378027
GMPAntisera, Control For Nontreponemal Tests866.382029
GMQAntigens, Nontreponemal, All866.3820232
GMRSera, Reactive And Non-Specific Control, Fta-Abs Test866.383020
GMSAnti-Human Globulin, Fta-Abs Test866.383023
GMTAntigens, Ha, Treponema Pallidum866.383029
GMWTest, Sorbent, Fta-Abs866.383020
GMXAntisera, Fluorescent Antibody For Fta-Abs Test866.383020
JWLAntigen, Treponema Pallidum For Fta-Abs Test866.383024
LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum866.3830235
LSRReagent, Borrelia Serological Reagent866.38302111
MYRTest, Donor, Syphilis, Antigens, Treponemal866.383020
GPGAntigen, Latex Agglutination, Trichinella Spiralis866.385012
GPHAntiserum, Bentonite Flocculation, Trichinella Spiralis866.385010
GPIAntigen, Bentonite Flocculation, Trichinella Spiralis866.385010
MDTElisa, Trichinella Spiralis866.385010
GNDAntigen, Iha, T. Cruzi866.387010
GNEAntigen, Latex Agglutination, T. Cruzi866.387011
GNFAntigen, Cf, T. Cruzi866.387010
LOOReagent, Leishmanii Serological866.387012
MIUEnzyme Linked Immunosorbent Assay, T. Cruzi866.387016
MIVImmunofluorescent Assay, T. Cruzi866.387010
OUZNucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids866.387011
PITLeishmania Spp. Antigen Detection Assay866.387011
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster866.3900210
GQXAntiserum, Cf, Varicella-Zoster866.3900211
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster866.3900217
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays866.3920230
QCHAssayed Quality Control Material For Clinical Microbiology Assays866.392021
QTMAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.866.392020
GSQAntiserum, Vibrio Cholerae, All Varieties866.393023
QFOZika Virus Serological Reagents866.393524
NOPElisa, Antibody, West Nile Virus866.3940210
OSUDengue Serological Reagents866.394521
QCUDengue Virus Antigen Assay866.394521
OZBDengue Nucleic Acid Amplification Assay (Naat)866.394621
MZFTest, Hiv Detection866.395620
QSUPoint Of Care Hiv Serology Diagnostic And/Or Supplemental Test866.395620
QSTLab-Based Hiv Nat Diagnostic And/Or Supplemental Test866.395720
QSVPoint Of Care Hiv Nat Diagnostic And/Or Supplemental Test866.395720
QUMHuman Immunodeficiency Virus (Hiv) Viral Load Monitoring Test866.395820
PIICandida Species Nucleic Acid Detection System866.396023
QBXDirect Blood Bacterial Nucleic Acid Detection System866.396022
QMVDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness866.396623
SBTDevice To Detect Microbial Colonization Directly From Clinical Specimens.866.396721
PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System866.397024
PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System866.3975211
OCCRespiratory Virus Panel Nucleic Acid Assay System866.3980278
OEMHuman Metapneumovirus (Hmpv) Rna Assay System866.398026
OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay866.398021
OMGAntisera, Fluorescent, Human Metapneumovirus866.398024
OOUParainfluenza Multiplex Nucleic Acid Assay866.398025
OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay866.398020
OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay866.3980220
OZXMycoplasma Pneumoniae Dna Assay System866.398023
OZYChlamydophila Pneumoniae Dna Assay System866.398020
OZZBordetella Pertussis Dna Assay System866.398029
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents866.3981232
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test866.3981211
QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings866.398228
QWRSimple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings866.398223
QVPSars-Cov-2 Serology Test866.398325
QWBOver-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens866.398422
QYTOver-The-Counter Covid-19 Antigen Test866.3984213
QBHLower Respiratory Microbial Nucleic Acid Detection System866.398522
QDPRespiratory Panel866.398522
SBZTest For Detection Of Antibodies Associated With Syphilis Performed By Lay Users866.398621
SCAMulti-Analyte Respiratory Virus Antigen Detection Test866.3987211
QSNOrthopedic Infection Microbial Multiplex Nucleic Acid Detection System866.398821
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System866.3990237
PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System866.399025
PIQReagents For Detection Of Norovirus Nucleic Acid866.399021
QPODevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples866.295221
QIDDevice To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens866.400221
PGVAnti-Phospholipase A2 Receptor866.578022
NZBQuality Control Material, Genetics, Dna866.591024
QIGQuality Control Material, Genetics, Rna866.591020
SCUDna And Rna Oncology Controls866.591020
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