Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- GOHAntigens, Cf (Including Cf Control), Poliovirus 1-31Product Code
- GOIAntiserum, Fluorescent, Rabies Virus2Product Code
- GOJAntisera, Neutralization, Rubella2Product Code
- GOKAntisera, Hai (Including Hai Control), Rubella2Product Code
- GOLAntigen, Ha (Including Ha Control), Rubella2Product Code
- GOMAntisera, Cf, Rubella2Product Code
- GONAntigen, Cf (Including Cf Control), Rubella2Product Code
- GOOAntisera, Fluorescent, All Globulins, Salmonella Spp.2Product Code
- GOPAntisera, C. Acnes (553, 605)1Product Code
- GOSAntiserum, Fluorescent, C. Diphtheriae1Product Code
- GOTAntigen, B. Parapertussis1Product Code
- GOWAntisera, Agglutinating, B. Parapertussis1Product Code
- GOXAntigen, B. Pertussis1Product Code
- GOYAntisera, Agglutinating, B. Pertussis, All1Product Code
- GOZAntisera, Fluorescent, B. Pertussis1Product Code
- OUYTrichomonas Vaginalis Nucleic Acid Amplification Test System2Product Code
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-331Product Code
- GOEAntisera, Fluorescent, Poliovirus 1-31Product Code
- GOFAntisera, Neutralization, Poliovirus 1-31Product Code
- GOGAntisera, Cf, Poliovirus 1-31Product Code
- QICHiv-1 Genotyping Assay Using Ngs Technology2Product Code
- GLZAntigens, If, Toxoplasma Gondii2Product Code
- GMAAntisera, Fluorescent, Sporothrix Schenekii1Product Code
- GMDAntisera, Latex Agglutination, Cryptococcus Neoformans2Product Code
- GMEAntisera, Fluorescent, Cryptococcus Neoformans2Product Code
- GMGAntigen, Latex Agglutination, Coccidioides Immitis2Product Code
- GMHAntiserum, Positive Control, Coccidioides Immitis2Product Code
- GMIAntigen, Cf And / Or Id, Coccidioides Immitis2Product Code
- GMJAntigens, Histoplasma Capsulatum, All2Product Code
- GMKAntiserum, Positive Control, Histoplasma Capsulatum2Product Code
- GMLAntisera, Fluorescent, Histoplasma Capsulatum2Product Code
- GMMAntigens, Iha, Toxoplasma Gondii2Product Code
- GMNAntigens, Cf, Toxoplasma Gondii2Product Code
- GMOAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.2Product Code
- GMPAntisera, Control For Nontreponemal Tests2Product Code
- GMQAntigens, Nontreponemal, All2Product Code
- GMRSera, Reactive And Non-Specific Control, Fta-Abs Test2Product Code
- GMSAnti-Human Globulin, Fta-Abs Test2Product Code
- GMTAntigens, Ha, Treponema Pallidum2Product Code
- GMWTest, Sorbent, Fta-Abs2Product Code
- GMXAntisera, Fluorescent Antibody For Fta-Abs Test2Product Code
- GMYAntisera, Fluorescent, All Types, Escherichia Coli1Product Code
- GMZAntigens, All Types, Escherichia Coli1Product Code
- GNAAntisera, All Types, Escherichia Coli1Product Code
- GNBAntisera, All Types, Shigella Spp.2Product Code
- GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.2Product Code
- GNDAntigen, Iha, T. Cruzi1Product Code
- GNEAntigen, Latex Agglutination, T. Cruzi1Product Code
- GNFAntigen, Cf, T. Cruzi1Product Code
- GNGAntigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-61Product Code
- GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni1Product Code
- GNIAntisera, Neutralization, Echovirus 1-341Product Code
- GNJAntigens, Ha, Echovirus 1-341Product Code
- GNKAntisera, Cf, Echovirus 1-341Product Code
- GNLAntigens, Cf (Including Cf Control), Echovirus 1-341Product Code
- GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-61Product Code
- GNNAntisera, Neutralization, Coxsackievirus A 1-24, B 1-61Product Code
- GNOAntisera, Cf, Coxsackievirus A 1-24, B 1-61Product Code
- GNPAntiserum, Cf, Epstein-Barr Virus1Product Code
- GNQAntigen, Cf (Including Cf Control), Epstein-Barr Virus1Product Code
- GNRAntisera, Neutralization, Influenza Virus A, B, C1Product Code
- GNSAntisera, Hai, Influenza Virus A, B, C1Product Code
- GNTAntigens, Ha (Including Ha Control), Influenza Virus A, B, C1Product Code
- GNWAntisera, Cf, Influenza Virus A, B, C1Product Code
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C1Product Code
- GNYAntisera, Fluorescent, Adenovirus 1-331Product Code
- GNZAntisera, Neutralization, Adenovirus 1-331Product Code
- GOAAntisera, Cf, Adenovirus 1-331Product Code
- GOBAntigens, Ha (Including Ha Control), Adenovirus 1-331Product Code
- GOCAntisera, Hai, Adenovirus 1-331Product Code
- GPDAntigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus1Product Code
- GPEAntisera, Positive Control, Echinococcus Spp.1Product Code
- GPFAntigen, Agglutinating, Echinococcus Spp.1Product Code
- GPGAntigen, Latex Agglutination, Trichinella Spiralis1Product Code
- GPHAntiserum, Bentonite Flocculation, Trichinella Spiralis1Product Code
- GPIAntigen, Bentonite Flocculation, Trichinella Spiralis1Product Code
- GPJAntiserum, Fluorescent, Q Fever1Product Code
- GPKAntiserum, Rickettsial Pox1Product Code
- GPMAntiserum, Murine Typhus Fever1Product Code
- GPNAntiserum, Typhus Fever1Product Code
- GPOAntigen, Cf, Typhus Fever Group1Product Code
- GPPAntiserum, Rocky Mountain Spotted Fever1Product Code
- GPQAntigen, Cf, Spotted Fever Group1Product Code
- GPRAntiserum, Cf, Q Fever1Product Code
- GPSAntigen, Cf, Q Fever1Product Code
- GPTAntiserum, Cf, Psittacosis (Chlamydia Group)1Product Code
- GPWAntigen, Cf, Psittacosis (Chlamydia Group)1Product Code
- GPXAntisera, Neutralizion, Reovirus 1-31Product Code
- GPYAntisera, Hai, Reovirus 1-31Product Code
- GPZAntisera, Cf, Reovirus 1-31Product Code
- GQAAntigens, Ha (Including Ha Control), Reovirus 1-31Product Code
- GQBAntigens, Cf (Including Cf Control), Reovirus 1-31Product Code
- GQCAntisera, Cf, Equine Encephalitis Virus, Eee, Wee1Product Code
- GQDAntigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee1Product Code
- GQEAntisera, Neutralization, All Types, Rhinovirus1Product Code
- GQFAntiserum, Neutralization, Respiratory Syncytial Virus1Product Code
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus1Product Code
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus2Product Code
- GQIAntiserum, Cf, Cytomegalovirus2Product Code
- GQJAntiserum, Cf, Lymphocytic Choriomeningitis Virus1Product Code
- GQKAntigen, Cf, Lymphocytic Choriomeningitis Virus1Product Code
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,22Product Code
- GQMAntisera, Neutralization, Herpesvirus Hominis2Product Code
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,22Product Code
- GQOAntisera, Cf, Herpesvirus Hominis 1,22Product Code
- GQPAntisera, Neutralization, Parainfluenza Virus 1-41Product Code
- GQQAntisera, Hai, Parainfluenza Virus 1-41Product Code
- GQRAntigens, Ha (Including Ha Control), Parainfluenza Virus 1-41Product Code
- GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-41Product Code
- GQTAntisera, Cf, Parainfluenza Virus 1-41Product Code
- GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster2Product Code
- GQXAntiserum, Cf, Varicella-Zoster2Product Code
- GQYAntigen, Ha (Including Ha Control), Mumps Virus1Product Code
- GQZAntiserum, Neutralization, Mumps Virus1Product Code
- GRAAntiserum, Fluorescent, Mumps Virus1Product Code
- GRBAntiserum, Cf, Mumps Virus1Product Code
- GRCAntigen, Cf (Including Cf Control), Mumps Virus1Product Code
- GRDAntiserum, Hai, Mumps Virus1Product Code
- GREAntiserum, Fluorescent, Rubeola1Product Code
- GRFAntiserum, Cf, Rubeola1Product Code
- GRGAntiserum, Hai, Rubeola1Product Code
- GRHAntigen, Ha (Including Ha Control), Rubeola1Product Code
- GRIAntiserum, Neutralization, Rubeola1Product Code
- GRJAntigen, Cf, (Including Cf Control), Rubeola1Product Code
- GRKAntisera, Fluorescent, Echovirus 1-341Product Code
- GRLAntigens, All Groups, Salmonella Spp.2Product Code
- GRMAntisera, All Groups, Salmonella Spp.2Product Code
- GROAntisera, Fluorescent, All Types, Hemophilus Spp.2Product Code
- GRPAntisera, All Types, H. Influenza2Product Code
- GRTAntiserum, Fluorescent, Mycobacterium Tuberculosis1Product Code
- GRWAntisera, All Fluorescent, Leptospira Spp.2Product Code
- GRXAntisera, All Leptospira Spp.2Product Code
- GRYAntigens, All, Leptospira Spp.2Product Code
- GRZAntisera, Fluorescent, All, Mycoplasma Spp.1Product Code
- GSAAntisera, All Mycoplasma Spp.1Product Code
- GSBAntigens, Cf, All, Mycoplasma Spp.1Product Code
- GSDAntiserum, Fluorescent, Erysipelothrix Rhusiopathiae1Product Code
- GSEAntiserum, Erysipelothrix Rhusiopathiae1Product Code
- GSFAntigen, Erysipelothrix Rhusiopathiae1Product Code
- GSGAntisera, Fluorescent, All Types, Listeria Monocytogenes1Product Code
- GSHAntisera, All Types, Listeria Monocytogenes1Product Code
- GSIAntigens, Slide And Tube, All Types, Listeria Monocytogenes1Product Code
- GSJAntiserum, Fluorescent, Francisella Tularensis2Product Code
- GSKAntiserum, Francisella Tularensis2Product Code
- GSLAntigens, Slide And Tube, Francisella Tularensis2Product Code
- GSMAntisera, Fluorescent, Brucella Spp.2Product Code
- GSNAntiserum, Positive And Negative Febrile Antigen Control Serum2Product Code
- GSOAntigens (Febrile), Agglutination, Brucella Spp.2Product Code
- GSPAntiserum, Fluorescent, Campylobacter Fetus1Product Code
- GSQAntiserum, Vibrio Cholerae, All Varieties2Product Code
- GSRAntisera, Fluorescent, Pseudomonas Pseudomallei2Product Code
- GSSAntisera, Fluorescent, Pseudomonas Aeruginosa2Product Code
- GSTAntiserum, Pseudomonas Pseudomallei2Product Code
- GSWAntiserum, Flavobacterium Meningosepticum, All Groups1Product Code
- GSXAntisera, Acinetobacter Calcoaceticus, All Varieties1Product Code
- GSYAntisera, Fluorescent, All Globulins, Proteus Spp.1Product Code
- GSZAntigens, Febrile (Weil-Felix), All Groups1Product Code
- GTAAntisera, All, Serratia Marcesans1Product Code
- GTBAntisera, Fluorescent, All Types, Klebsiella Spp.1Product Code
- GTCAntisera, All Types, Klebsiella Spp.1Product Code
- GTDAntisera, Fluorescent, All Globulins, Shigella Spp.2Product Code
- GTEAntisera, Arizona Spp., All1Product Code
- GTFAntisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.1Product Code
- GTHAntiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae2Product Code
- GTIAntisera, Fluorescent, All Groups, N. Meningitidis2Product Code
- GTJAntisera, All Groups, N. Meningitidis2Product Code
- GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.1Product Code
- GTOAnti-Streptokinase1Product Code
- GTPExoenzymes, Multiple, Streptococcal1Product Code
- GTQAntistreptolysin - Titer/Streptolysin O Reagent1Product Code
- GTRAntideoxyribonuclease, Streptococcus Spp.1Product Code
- GTXAntisera, Fluorescent, All Groups, Streptococcus Spp.1Product Code
- GTYAntigens, All Groups, Streptococcus Spp.1Product Code
- GTZAntisera, All Groups, Streptococcus Spp.1Product Code
- GWBAntisera, Fluorescent, All Types, Streptococcus Pneumoniae1Product Code
- GWCAntisera, All Types, Streptococcus Pneumoniae1Product Code
- GWDIndirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp2Product Code
- JRWAntisera, Fluorescent, B. Parapertussis1Product Code
- JRYAntiserum, Fluorescent, Epstein-Barr Virus1Product Code
- JWKAntigen, Positive Control, Cryptococcus Neoformans2Product Code
- JWLAntigen, Treponema Pallidum For Fta-Abs Test2Product Code
- JWTAntigen, Cf, Aspergillus Spp.1Product Code
- JWWAntigen, Cf, B. Dermatitidis2Product Code
- KFGAntiserum, Positive Control, Aspergillus Spp.1Product Code
- KFHAntiserum, Positive Control, Blastomyces Dermatitidis2Product Code
- KFIStrip, Virulence, Corynebacterium Diphtheriae1Product Code
- KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.2Product Code
- KLHAntisera, C. Acnes1Product Code
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella2Product Code
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster2Product Code
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus2Product Code
- LGBGonococcal Antibody Tests3Product Code
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific2Product Code
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii2Product Code
- LHJStaphylococcus Aureus Protein A Insoluble1Product Code
- LHKAntigen, Id, Candida Albicans2Product Code
- LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent2Product Code
- LHTStaphylococcus Aureus Somatic Antigens1Product Code
- LHWErythrocyte Suspension, Multi Species, Serological Reagent And Equipment1Product Code
- LIAAntigens, All Groups, Shigella Spp.2Product Code
- LICAntiserum, Coagglutination (Direct) Neisseria Gonorrhoeae2Product Code
- LINAntisera, Conjugated Fluorescent, Cytomegalovirus2Product Code
- LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum2Product Code
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus1Product Code
- LIRAntigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae2Product Code
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg1Product Code
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)1Product Code
- LJKAntisera, If, Toxoplasma Gondii2Product Code
- LJNAntibody Igm, If, Epstein-Barr Virus1Product Code
- LJOAntigen, Iha, Cytomegalovirus2Product Code
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis1Product Code
- LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus1Product Code
- LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.1Product Code
- LKCAntigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus2Product Code
- LKHAntisera, Immunoperoxidase, Chlamydia Spp.1Product Code
- LKIAntisera, Fluorescent, Chlamydia Spp.1Product Code
- LKQAntibody Igm,If, Cytomegalovirus Virus2Product Code
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa1Product Code
- LLADirect Agglutination Test, Toxoplasma Gondii2Product Code
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus1Product Code
- LOLHepatitis A Test (Antibody And Igm Antibody)2Product Code
- LOOReagent, Leishmanii Serological1Product Code
- LQFDna-Reagents, Mycobacterium Spp.1Product Code
- LQGDna-Reagents, Mycoplasma Spp.1Product Code
- LQHDna-Reagents, Legionella2Product Code
- LQNLatex Agglutination Assay, Rubella2Product Code
- LQODna-Reagents, Campylobacter Spp.1Product Code
- LQPCampylobacter Spp.1Product Code
- LRFCandida Spp., Direct Antigen, Id2Product Code
- LSDRubella, Other Assays2Product Code
- LSEEpstein-Barr Virus, Other1Product Code
- LSFDna-Reagents, Epstein-Barr Virus1Product Code
- LSGCandida Species, Antibody Detection2Product Code
- LSHAntigen, Blastomyces Dermatitidis, Other2Product Code
- LSIAntiserum, Blastomyces Dermatitidis, Other2Product Code
- LSJAntigen, Rubella, Other2Product Code
- LSKDna-Reagents, Chlamydia1Product Code
- LSLDna-Reagents, Neisseria2Product Code
- LSMDna-Reagents, Salmonella Spp.2Product Code
- LSNDna-Reagents, Shigella Spp.2Product Code
- LSODna-Reagents, Cytomegalovirus2Product Code
- LSQReagent, Rickettsia Serological1Product Code
- LSRReagent, Borrelia Serological Reagent2Product Code
- K233367iDart Lyme IgG ImmunoBlot Kit2Cleared 510(K)
- K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit2Cleared 510(K)
- K220016Viramed Borrela All-In-One ViraChip Test Kit2Cleared 510(K)
- K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit2Cleared 510(K)
- K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit2Cleared 510(K)
- K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit2Cleared 510(K)
- K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit2Cleared 510(K)
- K202573LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus2Cleared 510(K)
- K202574LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus2Cleared 510(K)
- K200025Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit2Cleared 510(K)
- K200023Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit2Cleared 510(K)
- K193051LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set2Cleared 510(K)
- K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System2Cleared 510(K)
- K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System2Cleared 510(K)
- K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System2Cleared 510(K)
- K183446BioPlex 2200 Lyme Total2Cleared 510(K)
- K173496Sofia 2 Lyme FIA, Sofia Lyme Control Set2Cleared 510(K)
- K180264Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit2Cleared 510(K)
- K173691Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack2Cleared 510(K)
- K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)2Cleared 510(K)
- K172254Lyme B. burgdorferi (IgM) MarStripe Test2Cleared 510(K)
- K163713Sofia Lyme FIA, Sofia Lyme Control Set2Cleared 510(K)
- K163695Borrelia B31 ViraChip IgM Test Kit2Cleared 510(K)
- K163504Borrelia B31 ViraChip IgG Test Kit2Cleared 510(K)
- K163095Lyme B. burgdorferi (IgG) MarStripe Test2Cleared 510(K)
- K161513Anti-Borrelia burgdorferi US Westernblot (IgG)2Cleared 510(K)
- K142038EUROIMMUN LYME ELISA(IgG/IgM)2Cleared 510(K)
- K122979VIDAS LYME IGM2Cleared 510(K)
- K122986VIDAS LYME IGG2Cleared 510(K)
- K113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM2Cleared 510(K)
- K113846BORRELIA BURGDORFERI IGM BLOT TEST2Cleared 510(K)
- K113847BORRELIA BURGDORFERI IGG BLOT TEST2Cleared 510(K)
- K100728ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM2Cleared 510(K)
- K092693VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS2Cleared 510(K)
- K082329VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE2Cleared 510(K)
- K081362PLATELIA LYME IGM2Cleared 510(K)
- K080012PLATELIA LYME IGG ASSAY2Cleared 510(K)
- K062473LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 3108712Cleared 510(K)
- K051169BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT2Cleared 510(K)
- K051071VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT2Cleared 510(K)
- K033083BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM2Cleared 510(K)
- K033070BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM2Cleared 510(K)
- K032713BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG2Cleared 510(K)
- K003754IMMUNETICS C6 LYME ELISA KIT2Cleared 510(K)
- K994004QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT2Cleared 510(K)
- K991063QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-0242Cleared 510(K)
- K991062QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-0242Cleared 510(K)
- K991185BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM2Cleared 510(K)
- K991180BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM2Cleared 510(K)
- K984234QUANTA LITE LYME IGM ELISA2Cleared 510(K)
- K984222QUANTA LITE LYME IGG ELISA2Cleared 510(K)
- K984138APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM2Cleared 510(K)
- K980351BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT2Cleared 510(K)
- K981913PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY2Cleared 510(K)
- K983606IS BORRELIA BURGDORFERI IGM TEST SYSTEM2Cleared 510(K)
- K983605IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM2Cleared 510(K)
- K971007LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)2Cleared 510(K)
- K971006LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)2Cleared 510(K)
- K970761LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)2Cleared 510(K)
- K970768HUMAN LYME IGM WESTERN BLOT KIT2Cleared 510(K)
- K971170CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)2Cleared 510(K)
- K971169CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)2Cleared 510(K)
- K974810ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL2Cleared 510(K)
- K974809ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL2Cleared 510(K)
- K965131BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM2Cleared 510(K)
- K965129BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM2Cleared 510(K)
- K951709MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM2Cleared 510(K)
- K950829MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM2Cleared 510(K)
- K953683MMUNO DOT BORRELIA DOT BLOT M TEST2Cleared 510(K)
- K953682IMMUNO DOT BORRELIA DOT BLOT G TEST2Cleared 510(K)
- K943812VIDAS LYME SCREEN II2Cleared 510(K)
- K922578BARTELS LYME DISEASE IGM EIA2Cleared 510(K)
- K911627IMMUNODOT BORRELIA (LYME) TEST2Cleared 510(K)
- K911599IMMUNOWELL LYME (P39 RECOMBINANT) TEST2Cleared 510(K)
- K911590IMMUNOWELL BORRELIA (LYME)TEST2Cleared 510(K)
- K896378LYME-CHECK(TM) TEST KIT2Cleared 510(K)
- K904652LYME STAT M TEST KIT2Cleared 510(K)
- K904893FIAX LYME M TEST KIT2Cleared 510(K)
- K910230LYME-SPOT IF KIT2Cleared 510(K)
- K900206LYME DISEASE IGM ELISA2Cleared 510(K)
- K911496FASTTECH SYSTEM 12Cleared 510(K)
- K903013LYME IGM ELISA TEST2Cleared 510(K)
- K911330LYME IGM MICROASSAY2Cleared 510(K)
- K910899LYME DISEASE MICROASSAY2Cleared 510(K)
- K911145BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST2Cleared 510(K)
- K8957133M IGG FASTLYME(TM) TEST2Cleared 510(K)
- K900572LYME IGM MICROASSAY2Cleared 510(K)
- K900196LYME IGM ELISA TEST SYSTEM2Cleared 510(K)
- K901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE2Cleared 510(K)
- K895292LYME IGG ELISA TEST SYSTEM2Cleared 510(K)
- K894410IMMUNODOT LYME TEST2Cleared 510(K)
- K894609MARDX LYME DISEASE IFA (IGM) TEST SYSTEM2Cleared 510(K)
- K894293MARDX LYME DISEASE EIA (IGM) TEST SYSTEM2Cleared 510(K)
- K894224MARDX LYME DISEASE EIA (IGG) TEST SYSTEM2Cleared 510(K)
- K892206MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM2Cleared 510(K)
- K890843LYME DISEASE MICROASSAY2Cleared 510(K)
- K890053MARDX LYME DISEASE IGG IFA TEST SYSTEM2Cleared 510(K)
- K885290BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY2Cleared 510(K)
- K885294BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM2Cleared 510(K)
- K885293BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM2Cleared 510(K)
- K890281HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES2Cleared 510(K)
- K883767LYME DISEASE IFA (IGM)2Cleared 510(K)
- K885317LYME ELISA TEST SYSTEM2Cleared 510(K)
- K883544LYME FAST TEST2Cleared 510(K)
- K883487LYME DISEASE IFA (IGG)2Cleared 510(K)
- K880476LYME DISEASE ELISA2Cleared 510(K)
- K875286LYME STAT TEST KIT2Cleared 510(K)
- K872247FIAX TEST KIT FOR LYME DISEASE ANTIBODIES2Cleared 510(K)
- K871246IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI2Cleared 510(K)
- LYFPneumocystis Carinii2Product Code
- LYRHelicobacter Pylori1Product Code
- MBTDna-Probe, Reagent, Histoplasma Capsulatum2Product Code
- MCCDna-Probe, Haemophilus Spp.2Product Code
- MCDAntigen, Ebv, Capsid1Product Code
- MCERespiratory Syncytial Virus - Elisa1Product Code
- MCGDna-Probe, Agent, Listeria1Product Code
- MCSDna-Probe, Staphylococcus Aureus1Product Code
- MCTDna-Probe, Strep Pneumoniae1Product Code
- MDCDna-Probe - Blastomyces Dermatitidis2Product Code
- MDEDna-Probe, Reagents, Cryptococcal2Product Code
- MDFDna-Probe, Reagents, Coccidioides Immitis2Product Code
- MDJReagents, Cysticercosis1Product Code
- MDKDna-Probe, Reagents, Streptococcal1Product Code
- MDTElisa, Trichinella Spiralis1Product Code
- MDUAntigen, Elisa, Cryptococcus2Product Code
- MGMC. Trachomatis (Chlamydia Group)1Product Code
- MHIGiardia Spp.2Product Code
- MHJCryptosporidium Spp.2Product Code
- MIUEnzyme Linked Immunosorbent Assay, T. Cruzi1Product Code
- MIVImmunofluorescent Assay, T. Cruzi1Product Code
- MIYEnzyme Linked Immunosorbent Assay, Coccidioides Immitis2Product Code
- MIZEnzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum2Product Code
- MJHLegionella, Spp., Elisa2Product Code
- MJLEia, Blastomyces Dermatitidis2Product Code
- MKZDna Probe, Nucleic Acid Amplification, Chlamydia1Product Code
- MSQTest, Urea (Breath Or Blood)1Product Code
- MWASystem, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex2Product Code
- MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-12Product Code
- MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-22Product Code
- NDZAssay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis1Product Code
- NGSAssay, Endotoxin Activity, Chemiluminescent2Product Code
- NHTAssay, Nucleic Acid Amplification, Bacillus Anthracis2Product Code
- NHYAssay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus1Product Code
- NHZAssay, Direct, Nucleic Acid Amplification, Parainfluenza Virus1Product Code
- NIAAssay, Direct, Nucleic Acid Amplification, Influenza Virus1Product Code
- NJOSystem, Mycolic Acid Analysis, Mycobacterium Tuberculosis1Product Code
- NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1Product Code
- NOMAntigen, Galactomannan, Aspergillus Spp.1Product Code
- NOPElisa, Antibody, West Nile Virus2Product Code
- NPOKit, Immunochromatographic, Bacillus Anthracis Differential Antibody2Product Code
- NQZAntigen, Invasive Fungal Pathogens2Product Code
- NRLEnzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis2Product Code
- NTMAntigen, Inflammatory Response Marker, Sepsis2Product Code
- NVQBacteriophage And Controls, B. Anthracis Lysis2Product Code
- NWZGas Chromatography, Bacillus Anthracis Membrane Fatty Acids2Product Code
- NXDNucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna2Product Code
- NXXFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus1Product Code
- OAHFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis1Product Code
- OAIAssay, Enterovirus Nucleic Acid2Product Code
- OAXPlasmodium Spp. Detection Reagents2Product Code
- OMSNovel Influenza A Virus, A/H5 Ns1 Protein2Product Code
- OOUParainfluenza Multiplex Nucleic Acid Assay2Product Code
- OCCRespiratory Virus Panel Nucleic Acid Assay System2Product Code
- OEHJoint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit2Product Code
- OEMHuman Metapneumovirus (Hmpv) Rna Assay System2Product Code
- OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay2Product Code
- OJYDevice To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers2Product Code
- OMGAntisera, Fluorescent, Human Metapneumovirus2Product Code
- OMIMultiplex Flow Immunoassay, T. Gondii, Rubella And Cmv2Product Code
- OPLMultiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus2Product Code
- OPMMultiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 22Product Code
- OQOHerpes Simplex Virus Nucleic Acid Amplification Assay2Product Code
- OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification2Product Code
- OSUDengue Serological Reagents2Product Code
- OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay2Product Code
- OUCNorovirus Serological Reagent2Product Code
- OUZNucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids1Product Code
- OVFAssay, Direct, Nucleic Acid Amplification, Q Fever1Product Code
- OWFImmunohistochemical Assay, Helicobacter Pylori1Product Code
- OYPAnti-Jcv Antibody Detection Assay2Product Code
- OYZGroup A Streptococcus Nucleic Acid Amplification Assay System1Product Code
- OZATest, Urea Adult And Pediatric (Breath),3Product Code
- OZBDengue Nucleic Acid Amplification Assay (Naat)2Product Code
- OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay2Product Code
- OZNC. Difficile Toxin Gene Amplification Assay2Product Code
- OZXMycoplasma Pneumoniae Dna Assay System2Product Code
- OZYChlamydophila Pneumoniae Dna Assay System2Product Code
- OZZBordetella Pertussis Dna Assay System2Product Code
- PAMGram-Positive Bacteria And Their Resistance Markers2Product Code
- PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System2Product Code
- PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System2Product Code
- PCLEnzyme Linked Immunoabsorbent Assay, Rubeola Igm1Product Code
- PENGram-Negative Bacteria And Associated Resistance Markers2Product Code
- PEOFungal Organisms, Nucleic Acid-Based Assay2Product Code
- PEUSystem, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen2Product Code
- PEXSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates2Product Code
- PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples2Product Code
- PIICandida Species Nucleic Acid Detection System2Product Code
- PIQReagents For Detection Of Norovirus Nucleic Acid2Product Code
- PITLeishmania Spp. Antigen Detection Assay1Product Code
- PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System2Product Code
- PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays2Product Code
- PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens2Product Code
- QBHLower Respiratory Microbial Nucleic Acid Detection System2Product Code
- PRERt-Qpcr Assay For Mrna Transcript Immune Biomarkers2Product Code
- PRIProcalcitonin Assay2Product Code
- PSZDevices Detecting Influenza A, B, And C Virus Antigens2Product Code
- PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission2Product Code
- PUQMultiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm2Product Code
- QBXDirect Blood Bacterial Nucleic Acid Detection System2Product Code
- QCHAssayed Quality Control Material For Clinical Microbiology Assays2Product Code
- QCUDengue Virus Antigen Assay2Product Code
- QDPRespiratory Panel2Product Code
- QFSMonocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment2Product Code
- QLXNucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna2Product Code
- QMINucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna2Product Code
- QMVDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness2Product Code
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents2Product Code
- QPSImmunoassay For Host Biomarkers Of Infection2Product Code
- QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test2Product Code
- QSTLab-Based Hiv Nat Diagnostic And/Or Supplemental Test2Product Code
- QSUPoint Of Care Hiv Serology Diagnostic And/Or Supplemental Test2Product Code
- QSVPoint Of Care Hiv Nat Diagnostic And/Or Supplemental Test2Product Code
- QTMAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.2Product Code
- QUTDeformability Cytometry For Sepsis Risk Assessment2Product Code
- SCXImmunoassay For Host Biomarkers Of Sepsis2Product Code
- Subpart F—Immunological Test SystemsCFR Sub-Part
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Sofia 2 Lyme FIA, Sofia Lyme Control Set
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K173496
- 510(k) Type
- Dual Track
- Applicant
- Quidel Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/30/2018
- Days to Decision
- 290 days
- Submission Type
- Summary