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
- K242022Access Toxo IgG2Cleared 510(K)
- K242095Access Toxo IgM II2Cleared 510(K)
- K233932Alinity i Toxo IgM2Cleared 510(K)
- K210596ARCHITECT Toxo IgG2Cleared 510(K)
- K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl2Cleared 510(K)
- K142826ADVIA Centaur Toxoplasma M (Toxo M)2Cleared 510(K)
- K132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II2Cleared 510(K)
- K131441LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II2Cleared 510(K)
- K101946VIDAS TOXO IGG AVIDITY2Cleared 510(K)
- K102681ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)2Cleared 510(K)
- K090847PLATELIA TOXO IGM KIT MODEL 262112Cleared 510(K)
- K073501ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG2Cleared 510(K)
- K080869ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC2Cleared 510(K)
- K052499DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS2Cleared 510(K)
- K032162ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY2Cleared 510(K)
- K031506ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY2Cleared 510(K)
- K013839BIO-RAD PLATELIA TOXO IGG TMB2Cleared 510(K)
- K013837BIO-RAD PLATELIA TOXO IGM TMB2Cleared 510(K)
- K012075IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM62Cleared 510(K)
- K012183BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY2Cleared 510(K)
- K010755BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY2Cleared 510(K)
- K003259ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,344792Cleared 510(K)
- K002453ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 344792Cleared 510(K)
- K001707DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM2Cleared 510(K)
- K993319VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 2102Cleared 510(K)
- K984317THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F2Cleared 510(K)
- K984170THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM2Cleared 510(K)
- K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 344692Cleared 510(K)
- K981498IS-TOXOPLASMA IGG TEST SYSTEM2Cleared 510(K)
- K971441QUANTA LITE TOXOPLASMA IGG2Cleared 510(K)
- K971989TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)2Cleared 510(K)
- K971672SERAQUEST TOXOPLASMA IGM2Cleared 510(K)
- K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY2Cleared 510(K)
- K962936IMMULITE TOXOPLASMA QUANTITATIVE IGG2Cleared 510(K)
- K962343TOXO IGG ELISA TEST2Cleared 510(K)
- K963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)2Cleared 510(K)
- K963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)2Cleared 510(K)
- K954576AXSYM TOXO IGM2Cleared 510(K)
- K954575AXSYM TOXO IGG ANTIBODY ASSAY2Cleared 510(K)
- K955760TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM2Cleared 510(K)
- K960092SERAQUEST TOXOPLASMA IGG2Cleared 510(K)
- K944867TOXOSTAT2Cleared 510(K)
- K950671IMMULITE TOXOPLASMA GONDII IGG2Cleared 510(K)
- K951495ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM2Cleared 510(K)
- K951636IMX TOXO IGG2Cleared 510(K)
- K945634IMX(R) TOXO IGM2Cleared 510(K)
- K931334VIDAS TOXO COMPETITION (TXC) ASSAY2Cleared 510(K)
- K922737VIDAS TOXO IG6 ASSAY (TX6)2Cleared 510(K)
- K923166VIDAS TOXOPLASMA GONDII IGM ASSSAY2Cleared 510(K)
- K921523OPUS(R) TOXO-G TEST SYSTEM2Cleared 510(K)
- K922585BARTELS TOXOPLASMA IGG EIA2Cleared 510(K)
- K922579BARTELS TOXOPLASMA IGM EIA2Cleared 510(K)
- K920702TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO2Cleared 510(K)
- K913731ENZYGNOST(R) TOXOPLASMOSIS/IGG2Cleared 510(K)
- K915891TOXO IGG ELISA TEST (MODIFIED)2Cleared 510(K)
- K913505ENZYGNOST TOXOPLASMOSIS/IGM2Cleared 510(K)
- K914852ELISA TOXO IGM2Cleared 510(K)
- K913787TOXOPLASMA IGM ELISA TEST SYSTEM2Cleared 510(K)
- K913106ABBOTT IMX TOXO IGM POSITIVE CONTROL2Cleared 510(K)
- K911834OPUS(R) ROZO2Cleared 510(K)
- K910416ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL2Cleared 510(K)
- K903968TOXO-CUBE2Cleared 510(K)
- K903324TOXO IGM ELISA TEST2Cleared 510(K)
- K902792TOXOPLASMA GONDII IGG2Cleared 510(K)
- K900818VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.2Cleared 510(K)
- K900354TOXO IGG ELISA TEST2Cleared 510(K)
- K894948PLATELIA TOXO IGM KIT2Cleared 510(K)
- K900655MODIFIED CAPTIA(R) TOXO-M2Cleared 510(K)
- K893200DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST2Cleared 510(K)
- K891781TOXO ELISA TEST SYSTEM2Cleared 510(K)
- K890031IMX TOXO IGG ANTIBODY ASSAY2Cleared 510(K)
- K890032IMX TOXO IGM ANTIBODY ASSAY2Cleared 510(K)
- K885344IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT2Cleared 510(K)
- K884249MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT2Cleared 510(K)
- K890154MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA2Cleared 510(K)
- K883937ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST2Cleared 510(K)
- K883720TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA2Cleared 510(K)
- K883936ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST2Cleared 510(K)
- K875258TOXOPLASMA GONDII IGG ELISA KIT2Cleared 510(K)
- K880918CAPTIA TOXO-G2Cleared 510(K)
- K875363SERODOT TOXOPLASMA IGG TEST KIT2Cleared 510(K)
- K875113TOXOSTAT M TEST KIT2Cleared 510(K)
- K873293BIOTROL TOXO ELISA TEST M2Cleared 510(K)
- K873294BIOTROL TOXO ELISA TEST G2Cleared 510(K)
- K875109DETECTADOT SYSTEM 2000 TOXO IGG TEST2Cleared 510(K)
- K874594TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 55602Cleared 510(K)
- K872070CHROMOTITRE E.I.A. TOXOPLASMA IGM2Cleared 510(K)
- K871746CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY2Cleared 510(K)
- K871905TOXOPLASMA GONDII IGG ELISA2Cleared 510(K)
- K872252MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT2Cleared 510(K)
- K870753TOXOPLASMA IGM MICROASSAY2Cleared 510(K)
- K865068ACCUPOINT TOXO2Cleared 510(K)
- K863813TOXOPLASMA IGG MICROASSAY2Cleared 510(K)
- K863363CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY2Cleared 510(K)
- K862196TOXONOSTIKA IGM MICROELISA SYSTEM2Cleared 510(K)
- K862189ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM2Cleared 510(K)
- K862216TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)2Cleared 510(K)
- K861458MUREX SUDS TOXO2Cleared 510(K)
- K860773TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 45602Cleared 510(K)
- K850567ABBOTT TOXO-M EIA DIAGNOSTIC KIT2Cleared 510(K)
- K843417CORDIA T-M2Cleared 510(K)
- K842797TOXOPLASMA GONDII IGM EIA TEST KIT2Cleared 510(K)
- K842528AMIZYME-TOXOPLASMA GONDII KIT2Cleared 510(K)
- K840879TOXO-G EIA DIAGNOSTIC KIT2Cleared 510(K)
- K833829TOXOPLASMA GOND II IGG DIA TEST KIT2Cleared 510(K)
- K813221TOXOELISA TEST KIT2Cleared 510(K)
- 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
- 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
- QGNLateral Flow Immunochromatography Assay For Host Infection Biomarkers2Product 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
- PGHHsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel2Product 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
- PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System2Product 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
- PYNFish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.2Product Code
- QAACoccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens2Product Code
- QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates2Product 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
- QDZQualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection2Product Code
- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections2Product Code
- QFAAssay For Detection Of Proteases In Chronic Wounds2Product Code
- QFOZika Virus Serological Reagents2Product 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
- QNJMass Spectrometry, Microorganism Identification, Blood Culture2Product Code
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents2Product Code
- QPSImmunoassay For Host Biomarkers Of Infection2Product Code
- QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry2Product Code
- QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test2Product Code
- PZFMers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System2Product Code
- QDSMers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System2Product 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
- QXALateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection2Product Code
- SCXImmunoassay For Host Biomarkers Of Sepsis2Product Code
- SEIQualitative And Quantitative Hepatitis B Virus Antibody Assays2Product 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
OPUS(R) ROZO
- Page Type
- Cleared 510(K)
- 510(k) Number
- K911834
- 510(k) Type
- Traditional
- Applicant
- PB DIAGNOSTIC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/12/1991
- Days to Decision
- 109 days
- Submission Type
- Statement