Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MiscellaneousMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- CZQBence-Jones Protein, Antigen, Antiserum, Control2Product Code
- CZRHemopexin, Rhodamine, Antigen, Antiserum, Control2Product Code
- CZSRetinol-Binding Protein, Antigen, Antiserum, Control1Product Code
- CZTHemopexin, Fitc, Antigen, Antiserum, Control2Product Code
- CZWComplement C3, Antigen, Antiserum, Control2Product Code
- CZXHemopexin, Antigen, Antiserum, Control2Product Code
- CZYComplement C1s, Antigen, Antiserum, Control2Product Code
- CZZHaptoglobin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DABHaptoglobin, Fitc, Antigen, Antiserum, Control2Product Code
- DACComplement C3b Activator, Antigen, Antiserum, Control2Product Code
- DADHaptoglobin, Antigen, Antiserum, Control2Product Code
- DAEComplement C9, Antigen, Antiserum, Control2Product Code
- DAFGamma Globulin, Fitc, Antigen, Antiserum, Control2Product Code
- DAGComplement C8, Antigen, Antiserum, Control2Product Code
- DAHGamma Globulin, Antigen, Antiserum, Control2Product Code
- DAIComplement C1r, Antigen, Antiserum, Control2Product Code
- DAJFree Secretory Component, Antigen, Antiserum, Control2Product Code
- DAKComplement C1q, Antigen, Antiserum, Control2Product Code
- DALFraction Iv-5, Antigen, Antiserum, Control1Product Code
- DAMHemoglobin, Chain Specific, Antigen, Antiserum, Control2Product Code
- DANFibrinopeptide A, Antigen, Antiserum, Control2Product Code
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control2Product Code
- DAQIgg (Fd Fragment Specific), Antigen, Antiserum, Control1Product Code
- DASIgg (Fc Fragment Specific), Antigen, Antiserum, Control1Product Code
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)2Product Code
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)2Product Code
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)2Product Code
- CGMMethod, Immunodiffusion, Immunoglobulins (G, A, M)2Product Code
- CHNImmunochemical, Ceruloplasmin2Product Code
- CZJIgd, Antigen, Antiserum, Control2Product Code
- CZKIga, Rhodamine, Antigen, Antiserum, Control2Product Code
- CZLIga, Peroxidase, Antigen, Antiserum, Control2Product Code
- CZMIga, Ferritin, Antigen, Antiserum, Control2Product Code
- CZNIga, Fitc, Antigen, Antiserum, Control2Product Code
- CZOInter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control1Product Code
- CZPIga, Antigen, Antiserum, Control2Product Code
- DAWAlpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DAYComplement C5, Antigen, Antiserum, Control2Product Code
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control2Product Code
- DBCAlpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DBEAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBFFerritin, Antigen, Antiserum, Control2Product Code
- DBHFc, Rhodamine, Antigen, Antiserum, Control1Product Code
- DBIComplement C4, Antigen, Antiserum, Control2Product Code
- DBJAntiparietal Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBKFc, Fitc, Antigen, Antiserum, Control1Product Code
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBNFc, Antigen, Antiserum, Control1Product Code
- DBYFab, Rhodamine, Antigen, Antiserum, Control1Product Code
- DCBFab, Fitc, Antigen, Antiserum, Control1Product Code
- DCEFab, Antigen, Antiserum, Control1Product Code
- DCFAlbumin, Antigen, Antiserum, Control2Product Code
- DCHSystem, Test, C-Reactive Protein, Rhodamine2Product Code
- DCJBeta-Globulin, Antigen, Antiserum, Control1Product Code
- DCKC-Reactive Protein, Antigen, Antiserum, And Control2Product Code
- DCNSystem, Test, C-Reactive Protein2Product Code
- DCOAlpha-Globulin, Antigen, Antiserum, Control1Product Code
- DCTCeruloplasmin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DCYCeruloplasmin, Fitc, Antigen, Antiserum, Control2Product Code
- DDBCeruloplasmin, Antigen, Antiserum, Control2Product Code
- DDCThyroglobulin, Antigen, Antiserum, Control2Product Code
- DDDTransferrin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDGTransferrin, Antigen, Antiserum, Control2Product Code
- DDITransferrin, Fitc, Antigen, Antiserum, Control2Product Code
- DDJThyroglobulin, Fitc, Antigen, Antiserum, Control2Product Code
- DDKBeta-2-Glycoprotein Iii, Antigen, Antiserum, Control1Product Code
- DDLThyroglobulin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDNBeta-2-Glycoprotein I, Antigen, Antiserum, Control1Product Code
- DDOMyoglobin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDRMyoglobin, Antigen, Antiserum, Control2Product Code
- DDSPrealbumin, Fitc, Antigen, Antiserum, Control1Product Code
- DDTAlpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDYAlpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control2Product Code
- DDZAlbumin, Fitc, Antigen, Antiserum, Control2Product Code
- DEAMyoglobin, Fitc, Antigen, Antiserum, Control2Product Code
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control2Product Code
- DECInter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control1Product Code
- DEFAlpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEGLactoferrin, Antigen, Antiserum, Control1Product Code
- DEHLambda, Antigen, Antiserum, Control2Product Code
- DEIAlpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control2Product Code
- DEJAlpha-2-Glycoproteins, Antigen, Antiserum, Control1Product Code
- DEKKappa, Rhodamine, Antigen, Antiserum, Control2Product Code
- DELLipoprotein X, Antigen, Antiserum, Control1Product Code
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control2Product Code
- DENAlpha-1-T-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEOKappa, Fitc, Antigen, Antiserum, Control2Product Code
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control2Product Code
- DESLambda, Fitc, Antigen, Antiserum, Control2Product Code
- DETLactic Dehydrogenase, Antigen, Antiserum, Control1Product Code
- DEWIgg, Antigen, Antiserum, Control2Product Code
- DEXAlpha-1-B-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEZIgm, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFBAlpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control2Product Code
- DFFAlpha-1-Antichymotrypsin, Antigen, Antiserum, Control2Product Code
- DFGLambda, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFHKappa, Antigen, Antiserum, Control2Product Code
- DFITotal Spinal-Fluid, Antigen, Antiserum, Control1Product Code
- DFJAlbumin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFKIgg (Fab Fragment Specific), Antigen, Antiserum, Control1Product Code
- DFLIgm, Ferritin, Antigen, Antiserum, Control2Product Code
- DFMIge, Ferritin, Antigen, Antiserum, Control2Product Code
- DFOIgg, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFQSperm, Antigen, Antiserum, Control1Product Code
- DFSIgm, Fitc, Antigen, Antiserum, Control2Product Code
- DFTIgm, Antigen, Antiserum, Control2Product Code
- DFXSperm, Fitc, Antigen, Antiserum, Control1Product Code
- DFZIgg (Gamma Chain Specific), Antigen, Antiserum, Control2Product Code
- DGACohn Fraction Ii, Antigen, Antiserum, Control1Product Code
- DGCIge, Antigen, Antiserum, Control2Product Code
- DGDIgg, Ferritin, Antigen, Antiserum, Control2Product Code
- DGEIgd, Rhodamine, Antigen, Antiserum, Control2Product Code
- DGGIgd, Fitc, Antigen, Antiserum, Control2Product Code
- DGIBreast Milk, Rhodamine, Antigen, Antiserum, Control1Product Code
- DGJColostrum, Antigen, Antiserum, Control1Product Code
- DGKIgg, Fitc, Antigen, Antiserum, Control2Product Code
- DGLIge, Rhodamine, Antigen, Antiserum, Control2Product Code
- DGMBreast Milk, Antigen, Antiserum, Control1Product Code
- DGNBreast Milk, Fitc, Antigen, Antiserum, Control1Product Code
- DGPIge, Fitc, Antigen, Antiserum, Control2Product Code
- DGWSystem, Test, Hypersensitivity Pneumonitis2Product Code
- DGXNg1m(A), Antigen, Antiserum, Control1Product Code
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological2Product Code
- DHCSystem, Test, Systemic Lupus Erythematosus2Product Code
- DHINg3m(Bo), Antigen, Antiserum, Control1Product Code
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DHQNg3m(G), Antigen, Antiserum, Control1Product Code
- DHRSystem, Test, Rheumatoid Factor2Product Code
- K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)2Cleared 510(K)
- K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents2Cleared 510(K)
- K182747EliA RF IgM Immunoassay2Cleared 510(K)
- K162263Optilite Rheumatoid Factor Kit2Cleared 510(K)
- K160070Rheumatoid Factor (RF) Kit for use on SPAPLUS2Cleared 510(K)
- K143736ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA2Cleared 510(K)
- K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM2Cleared 510(K)
- K100499ORGENTEC RHEUMATOID FACTOR EIA2Cleared 510(K)
- K083080IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM2Cleared 510(K)
- K071247N LATEX RF KIT2Cleared 510(K)
- K060201OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.2Cleared 510(K)
- K041891MININEPH HUMAN RHEUMATOID FACTOR KIT2Cleared 510(K)
- K041863VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS2Cleared 510(K)
- K033802ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM2Cleared 510(K)
- K032535MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM2Cleared 510(K)
- K024067RHEUMATOID FACTOR (RF)2Cleared 510(K)
- K020972WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET2Cleared 510(K)
- K021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM2Cleared 510(K)
- K002609TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM2Cleared 510(K)
- K000534COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II2Cleared 510(K)
- K993557AUTOSTAT II RHEUMATOID FACTOR IGA ELISA2Cleared 510(K)
- K994338AUTOSTAT II RHEUMATOID FACTOR IGM ELISA2Cleared 510(K)
- K993843MDI RF TEST2Cleared 510(K)
- K993304AUTOSTAT II RHEUMATOID FACTOR IGG ELISA2Cleared 510(K)
- K991467K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET2Cleared 510(K)
- K991409K-ASSAY RHEUMATOID FACTOR2Cleared 510(K)
- K990587ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-012Cleared 510(K)
- K990035RF2Cleared 510(K)
- K984045RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS2Cleared 510(K)
- K983418THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL2Cleared 510(K)
- K983083QUANTA LITE RF IGG ELISA2Cleared 510(K)
- K983084QUANTA LITE RF IGA ELISA2Cleared 510(K)
- K981496COLOR-SLIDE RF2Cleared 510(K)
- K974889DIAMEDIX IS-RF TEST SYSTEM2Cleared 510(K)
- K974370RAPET RF2Cleared 510(K)
- K972456RHEUMACOL RHEUMATOID FACTOR TEST2Cleared 510(K)
- K973464QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)2Cleared 510(K)
- K972220RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT2Cleared 510(K)
- K971602ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT2Cleared 510(K)
- K971614QUANTA LITE RF IGM2Cleared 510(K)
- K971379TINAQUANT RHEUMATOID FACTOR ASSAY2Cleared 510(K)
- K971788SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR2Cleared 510(K)
- K970373RAICHEM RHEUMATOID FACTOR SPIA2Cleared 510(K)
- K962729HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY2Cleared 510(K)
- K962050THERATEST EL-RFSCR2Cleared 510(K)
- K964415N-ASSAY TIA RHEUMATOID FACTOR TEST KIT2Cleared 510(K)
- K964418N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET2Cleared 510(K)
- K962015RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST2Cleared 510(K)
- K963048IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT2Cleared 510(K)
- K961545QUALITROL RF CONTROLS2Cleared 510(K)
- K962836HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)2Cleared 510(K)
- K961169RHEUMATOID FACTOR LATEX SLIDE TEST KIT2Cleared 510(K)
- K960987LIQUICHEK RHEUMATOID FACTOR CONTROL2Cleared 510(K)
- K961277RF IGM ELISA TEST SYSTEM2Cleared 510(K)
- K960703RF-LATEX SEIKEN REAGENT SYSTEM2Cleared 510(K)
- K954892HYTEC AUTOMIMMUNE KIT (RF)2Cleared 510(K)
- K955086TEST, RHEUMATOID FACTOR2Cleared 510(K)
- K953520OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT2Cleared 510(K)
- K953261CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM2Cleared 510(K)
- K941398EL-RF/3 (IGM-IGG-IGA) KIT2Cleared 510(K)
- K942908IGM RF EIA2Cleared 510(K)
- K942328N LATEX RF2Cleared 510(K)
- K942272IGM RHEUMATOID FACTOR2Cleared 510(K)
- K933712EL-RF TEST SYSTEM: EL-RF-IGM KIT2Cleared 510(K)
- K932437EYE SPOT RF TEST2Cleared 510(K)
- K926569IMMUNO RA UNDILUTED2Cleared 510(K)
- K915320RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST2Cleared 510(K)
- K924036ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST2Cleared 510(K)
- K923578LIQUICHEK RHEUMATOID FACTOR CONTROL2Cleared 510(K)
- K923771PULSE RF TEST2Cleared 510(K)
- K922725TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL2Cleared 510(K)
- K924056ENCORE RHEUMATOID FACTOR EIA2Cleared 510(K)
- K922151WAKO AUTOKIT RF2Cleared 510(K)
- K920753RF STAT IGM TEST KIT2Cleared 510(K)
- K920220HEALTHTEST RHEUMATOID FACTOR ASSAY2Cleared 510(K)
- K920124TURBIQUANT2Cleared 510(K)
- K904310RHEUMAGEN RF T-CONTROL2Cleared 510(K)
- K910539RHEUMAJET RF2Cleared 510(K)
- K904498CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST2Cleared 510(K)
- K904105V-TREND TARGET RF TEST2Cleared 510(K)
- K903852RAPITEX(R) RF NEW2Cleared 510(K)
- K902462MODIFIED QM300 RHEUMATOID FACTOR TEST2Cleared 510(K)
- K896271QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)2Cleared 510(K)
- K894574TECHNICON DPA-1 SYSTEM RF METHOD2Cleared 510(K)
- K892445REAADS-RF TEST KIT-SEMIQUANTITATIVE2Cleared 510(K)
- K892444REAADS-RF TEST KIT-QUANTITATIVE2Cleared 510(K)
- K884180TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM2Cleared 510(K)
- K883536QM300 RHEUMATOID FACTOR ANTIGEN PACK2Cleared 510(K)
- K883538QM300 CALIBRATOR E PACK2Cleared 510(K)
- K883355UBI MAGIWEL RF-IGM QUANTITATIVE2Cleared 510(K)
- K880164RF CARD TEST & RF LIQUID TEST2Cleared 510(K)
- K874151RF DIPSTICK TEST KIT2Cleared 510(K)
- K873782REUMA TEST2Cleared 510(K)
- K873064AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT2Cleared 510(K)
- K871196RHEUMA-CHECK ENZYME IMMUNOASSAY TEST2Cleared 510(K)
- K871041RF MICROASSAY2Cleared 510(K)
- K863238READS RF TEST KIT FOR IGM RHEUMATOID FACTOR2Cleared 510(K)
- K855221SERATEST RF (HEMAGGLUTINATION) KIT2Cleared 510(K)
- K854222DIESSE RF TEST KIT2Cleared 510(K)
- K854820RA 80 EIKEN2Cleared 510(K)
- K853054RF CARD TEST2Cleared 510(K)
- K851537LASER RF CONTROL SERUM-QUALITY CONTROL SERUM2Cleared 510(K)
- K851099IGM RHEUMATOID FACTOR TEST KIT2Cleared 510(K)
- K850296LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS2Cleared 510(K)
- K850373ABBOTT RF EIA DIAGNOSTIC KIT2Cleared 510(K)
- K843896RHEUMADX LATEX AGGLUTINATION RHEUMATOID2Cleared 510(K)
- K841454RF TEST KIT2Cleared 510(K)
- K841146NCS RA LATEX TEST2Cleared 510(K)
- K840863SERATEST RF LATEX DETERMINATION2Cleared 510(K)
- K840005NABI RF-Q.S. TEST2Cleared 510(K)
- K840049SOPHEIA MP IGM RHEUMATOID FACTOR EIA2Cleared 510(K)
- K834391IMMUNO-RA2Cleared 510(K)
- K831941LEAP RHEUMATOID FACTOR TEST KIT2Cleared 510(K)
- K831597SERO/TEX RED CELL RF TEST2Cleared 510(K)
- K831467RA-CHECK2Cleared 510(K)
- K830832RHEUMATOID FACTOR-RAPID CARD TEST #651142Cleared 510(K)
- K830611RA SCREENING TEST2Cleared 510(K)
- K822905LATEST RF KIT FOR RHEUMATOID FACTOR2Cleared 510(K)
- K821941RHEUMATOID FACTOR REFERENCE PREPARA.2Cleared 510(K)
- K821319SERO/TEX RF TEST2Cleared 510(K)
- K813309RA-80 POSITIVE CONTROL2Cleared 510(K)
- K812972RA LATEX TEST2Cleared 510(K)
- K812968FIAX RHEUMATOID FACTOR TEST KIT2Cleared 510(K)
- K812882RHEUMATEX2Cleared 510(K)
- K811375BI-RA SLIDE TEST2Cleared 510(K)
- K810404RHEUMATOID FACTORS REFERENCE SERUM2Cleared 510(K)
- K810306RHEUMATOID FACTOR REAGENT TEST KIT2Cleared 510(K)
- K810221SCRIPPSERA THEUMATOID FACTOR REFER. CNTL2Cleared 510(K)
- K810141SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT2Cleared 510(K)
- K802448RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.2Cleared 510(K)
- K802688RHEUMATOID FACTOR TEST SYSTEMS2Cleared 510(K)
- K801961RF-II TEST KIT2Cleared 510(K)
- K800268AUTOMATED RHEMATOID FACTOR TEST (ARFT)2Cleared 510(K)
- K792697NORMAL GLOBULIN REAGENT2Cleared 510(K)
- K792695ANTI-GLOBULIN CONTROL2Cleared 510(K)
- K791507AGGLUTINOTEST-RHEUMATOID ARTHRITIS2Cleared 510(K)
- K792061CORDIA RF2Cleared 510(K)
- K790351RHEUMATELL2Cleared 510(K)
- K790012RHEUMOGEN TEST SYSTEM2Cleared 510(K)
- K771940QUANTROLS RF2Cleared 510(K)
- K771410RHEUMANOSTICON R2Cleared 510(K)
- K771552LAS-R RHEUMATOID FACTOR TEST2Cleared 510(K)
- K760043TEST, RHEUM. ARTH., CARD (MACRO-VUE)2Cleared 510(K)
- K760036TEST, LATEX SLIDE, RHEUMATOID FACTOR2Cleared 510(K)
- DHYNg4m(A), Antigen, Antiserum, Control1Product Code
- JFQP-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin2Product Code
- JFRIndirect Copper Assay, Ceruloplasmin2Product Code
- JHRRadioimmunoassay, Immunoglobulins (D, E)2Product Code
- JKMImmunochemical, Bence-Jones Protein2Product Code
- JNLImmunochemical, Thyroglobulin Autoantibody2Product Code
- JNMImmunochemical, Transferrin2Product Code
- JZGSystem, Test, Beta-2-Microglobulin Immunological2Product Code
- JZHFactor B, Antigen, Antiserum, Control2Product Code
- JZJPrealbumin, Antigen, Antiserum, Control1Product Code
- JZOSystem, Test, Thyroid Autoantibody2Product Code
- KHTFraction V, Antigen, Antiserum, Control1Product Code
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase2Product Code
- KTMC3-Indirect Immunofluorescent Solid Phase2Product Code
- KTOReagent, Immunoassay, Igg1Product Code
- KTPComplement C3b Activator Immunoassay Reagents2Product Code
- KTSSecond Antibody (Species Specific Anti-Animal Gamma Globulin)2Product Code
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls2Product Code
- LKJAntinuclear Antibody, Antigen, Control2Product Code
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control1Product Code
- LKOAnti-Rnp Antibody, Antigen And Control2Product Code
- LKPAnti-Sm Antibody, Antigen And Control2Product Code
- LLLExtractable Antinuclear Antibody, Antigen And Control2Product Code
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control2Product Code
- LSWAnti-Dna Antibody, Antigen And Control2Product Code
- MGAAlpha-1 Microglobulin, Antigen, Antiserum, Control1Product Code
- MIDSystem, Test, Anticardiolipin Immunological2Product Code
- MLEEnzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control2Product Code
- MLHStrip, Hama Igg, Elisa, In Vitro Test System2Product Code
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)2Product Code
- MQAAnti-Ribosomal P Antibodies2Product Code
- MSTAntibodies, Gliadin2Product Code
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)2Product Code
- MVEBiosensor, Immunoassay, Myoglobin2Product Code
- MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)2Product Code
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)2Product Code
- NBOAutoantibodies, Skin (Desmoglein 1 And Desmoglein 3)2Product Code
- NBSAutoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)2Product Code
- NBTAntibodies, Saccharomyces Cerevisiae (S.Cerevisiae)2Product Code
- NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)2Product Code
- NIYAutoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis2Product Code
- NJFAntibodies, Anti-Actin, Anti-Smooth Muscle2Product Code
- NOETest, System, Immunoassay, Lipoprotein-Associated Phospholipase A22Product Code
- NPHAntigen, Cartilage Oligomeric Matrix Protein (Comp)2Product Code
- NQDCardiac C-Reactive Protein, Antigen, Antiserum, And Control2Product Code
- NRIAutoantibodies, Nuclear Pore Glycoprotein Gp2102Product Code
- NRXComplement 4d (C4d) And Complement Receptor 1 (Cr1)2Product Code
- NSTAutoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking2Product Code
- NUMAutoantibodies, Nuclear Body Protein, Sp1002Product Code
- NWGAutoantibodies, Glutamic Acid Decarboxylase (Gad)2Product Code
- NXOCalprotectin, Fecal2Product Code
- NYOAutoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody2Product Code
- OBEAnti-Ss-A 52 Autoantibodies2Product Code
- OBZAlpha-1-Antitrypsin Kit, Qualitative Phenotype2Product Code
- OCNInsulin Autoantibody Kit2Product Code
- OEGAutoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 2302Product Code
- OIFTyrosine Phosphatase (Ia-2) Autoantibody Assay2Product Code
- OKMAntibodies, Outer-Membrane Proteins2Product Code
- OPNAuto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex2Product Code
- OPXImmunoglobulin A Kappa Heavy & Light Chain Combined2Product Code
- OPYIgal Heavy & Light Chain Combined2Product Code
- OQZAnti-Mutated Citrullinated Vimentin Igg2Product Code
- OSKAnti-Glutamate Receptor (Type Nmda) Ifa2Product Code
- OYLTryptase Assay System2Product Code
- PAFVoltage Gated Calcium Channel (Vgcc) Antibody Assay2Product Code
- PCG21-Hydroxylase Antibody (21-Ohab)2Product Code
- PCNImmunoglobulin G Kappa Heavy And Light Chain Combined2Product Code
- PCOImmunoglobulin G Lambda Heavy And Light Chain Combined2Product Code
- PDEImmunoglobulin M Kappa Heavy And Light Chain Combined2Product Code
- PDFImmunoglobulin M Lambda Heavy And Light Chain Combined2Product Code
- PETAnti-Ss-A Ro60 Autoantibodies2Product Code
- PHFZinc Transporter 8 Auto-Antibody2Product Code
- PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System2Product Code
- PNIAquaporin-4 Autoantibody2Product Code
- PTAGenetic Variant Detection And Health Risk Assessment System2Product Code
- PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens2Product Code
- PZHSerpina1 Variant Detection System2Product Code
- QATBrain Trauma Assessment Test2Product Code
- NZBQuality Control Material, Genetics, Dna2Product Code
- QUKHuman Leukocyte Antigen (Hla) Typing Companion Diagnostic Test2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- MicrobiologyReview Panel
- 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
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K032535
- 510(k) Type
- Special
- Applicant
- ROCHE DIAGNOSTICS CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/10/2003
- Days to Decision
- 23 days
- Submission Type
- Summary