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
- 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
- K213403Aptiva CTD Essential Reagent2Cleared 510(K)
- K190710EliA SymphonyS Immunoassay2Cleared 510(K)
- K180975QUANTA Flash HMGCR Reagents2Cleared 510(K)
- K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls2Cleared 510(K)
- K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols2Cleared 510(K)
- K142781ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA2Cleared 510(K)
- K141328QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS2Cleared 510(K)
- K141210QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS2Cleared 510(K)
- K122923QUANTA FLASH ENA72Cleared 510(K)
- K112996EUROIMMUN ANTI-ENA POOL ELISA (IGG)2Cleared 510(K)
- K113143IMMULISA SCI-70 ANTIBODY ELISA2Cleared 510(K)
- K102607FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS2Cleared 510(K)
- K072149ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-012Cleared 510(K)
- K053653FIDIS CONNECTIVE 10, MODEL MX0062Cleared 510(K)
- K050286FIDIS CONNECTIVE 82Cleared 510(K)
- K043067ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 4002Cleared 510(K)
- K041753AESKULISA ENA 6 S2Cleared 510(K)
- K040160QUANTA PLEX SLE PROFILE 82Cleared 510(K)
- K033528MESACUP-2 TEST JO-1, MODEL 107562Cleared 510(K)
- K032469AESKULISA ANA 8PRO2Cleared 510(K)
- K031450QUANTA PLEX ENA PROFILE 62Cleared 510(K)
- K030681QUANTA PLEX ENA PROFILE 52Cleared 510(K)
- K011140QUANTA PLEX ENA PROFILE 42Cleared 510(K)
- K010147ENA EIA KIT2Cleared 510(K)
- K010146ENA EIA KIT RANGE2Cleared 510(K)
- K010148ENA SCREEN EIA KIT2Cleared 510(K)
- K003054AUTOSTAT II ENA-6 PROFILE ELISA2Cleared 510(K)
- K003057AUTOSTAT II ENA-4 PROFILE ELISA2Cleared 510(K)
- K000751RHIGENE MESACUP2 TEST- SSB2Cleared 510(K)
- K000750RHIGENE MESACUP2 TEST- SCL-702Cleared 510(K)
- K000749RHIGENE MESACUP2 TEST- SSA2Cleared 510(K)
- K000489ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST2Cleared 510(K)
- K993839ENA PROFILE ELISA TEST SYSTEM2Cleared 510(K)
- K994029MDI SM TEST2Cleared 510(K)
- K993971MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM2Cleared 510(K)
- K991657QUANTA LITE ANA ELISA2Cleared 510(K)
- K990798AUTOSTAT II ANTI-JO-1 ELISA2Cleared 510(K)
- K990797AUTOSTAT II ANTI-SCL-70 ELISA2Cleared 510(K)
- K990627AUTOSTAT II ANTI-SS-A/RO ELISA2Cleared 510(K)
- K990626AUTOSTAT II ANTI-SS-B/LA ELISA2Cleared 510(K)
- K983921AUTOSTAT II ENA SCREEN ELISA2Cleared 510(K)
- K984462LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 2062Cleared 510(K)
- K983464THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE2Cleared 510(K)
- K983425THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET2Cleared 510(K)
- K983426THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC2Cleared 510(K)
- K983423THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE2Cleared 510(K)
- K983376THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S2Cleared 510(K)
- K982603QUANTA LITE CHROMATIN ELISA2Cleared 510(K)
- K982150EL-ANA PROFILES: EL-ENA/42Cleared 510(K)
- K982622EL-ANA PROFILES: EL-ENA/52Cleared 510(K)
- K981857QUANTA LITE TPO ELISA2Cleared 510(K)
- K980639SERAQUEST ANTI-SSB2Cleared 510(K)
- K980759DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM2Cleared 510(K)
- K970239IS-ANTI-SCL-70 TEST SYSTEM (720-280)2Cleared 510(K)
- K970218IS-ANTI-SSA TEST SYSTEM2Cleared 510(K)
- K970220IS-ANTI-SM TEST SYSTEM2Cleared 510(K)
- K970228IS-ANTI-JO-1 TEST SYSTEM2Cleared 510(K)
- K970237IS-ANTI-SSB TEST SYSTEM (720-260)2Cleared 510(K)
- K970238IS-ANTI-SM/RNP (720-270)2Cleared 510(K)
- K964787MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM2Cleared 510(K)
- K962731HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY2Cleared 510(K)
- K962727HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY2Cleared 510(K)
- K962728HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY2Cleared 510(K)
- K962578HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY2Cleared 510(K)
- K962719HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY2Cleared 510(K)
- K962720HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY2Cleared 510(K)
- K962722HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY2Cleared 510(K)
- K963275RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM2Cleared 510(K)
- K961913QUANTA LITE ENA 6 ELISA2Cleared 510(K)
- K955603RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM2Cleared 510(K)
- K955605RELISA JO-1 ANTIBODY TEST SYSTEM2Cleared 510(K)
- K955602RELSIA SCL-70 ANTIBODY TEST SYSTEM2Cleared 510(K)
- K955604RELISA SM/RNP ANTIBODY TEST SYSTEM2Cleared 510(K)
- K955133ORGENTEC ENASCREEN PIN IMMUNO ASSAY2Cleared 510(K)
- K955134ORGENTEC ENASCREEN ELISA ASSAY2Cleared 510(K)
- K954895HYTEC AUTOIMMUNE KIT (JO-1)2Cleared 510(K)
- K954894HYTEC AUTOIMMUNE KITS (SCL-70)2Cleared 510(K)
- K954890HYTEC AUTOMMUNE KIT (ENA)2Cleared 510(K)
- K952253ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT2Cleared 510(K)
- K952076HEMAGEN ENA SCREENING KIT (EIA METHOD)2Cleared 510(K)
- K952077HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)2Cleared 510(K)
- K950414HEMAGEN ENA SM/RMP KIT (EIA METHOD)2Cleared 510(K)
- K946121HEMAGEN ENA SS-A KIT (EIA METHOD)2Cleared 510(K)
- K946124HEMAGEN ENA JO-1 KIT (EIA METHOD)2Cleared 510(K)
- K946123HEMAGEN ENA SM KIT (EIA METHOD)2Cleared 510(K)
- K946122HEMAGEN ENA SCL-70 KIT (EIA METHOD)2Cleared 510(K)
- K946120HEMAGEN ENA SS-B KIT (EIA METHOD)2Cleared 510(K)
- K943291ANTI DS-DNA2Cleared 510(K)
- K944505DIASTAT ENA SINGLE WELL SCREEN KIT2Cleared 510(K)
- K943076QUANTA LITE ENA 5 ELISA KIT2Cleared 510(K)
- K940362ANA SCREEN ELISA TEST SYSTEM2Cleared 510(K)
- K935413ENA EIA TEST KIT2Cleared 510(K)
- K940622ELIAS ENA SCREEN (MICROTITER PLATE)2Cleared 510(K)
- K940229SYN ENA SCREEN (PIN PLATE)2Cleared 510(K)
- K935417JO-1 EIA TEST KIT2Cleared 510(K)
- K935419LA EIA TEST KIT2Cleared 510(K)
- K935418SCL-70 EIA TEST KIT2Cleared 510(K)
- K935828HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)2Cleared 510(K)
- K935129RELISA ENA ANTIBODY SCREENING TEST SYSTEM2Cleared 510(K)
- K934053QUANTA LITE(TM) HISTONE ELISA2Cleared 510(K)
- K932877DIASTAT ANTI-CENTROMERE KIT2Cleared 510(K)
- K932850ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN2Cleared 510(K)
- K931543ENCORE ENA COMBINED EIA2Cleared 510(K)
- K932419ANTI-SS-B/LA ANTIBODY TEST2Cleared 510(K)
- K931495ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT2Cleared 510(K)
- K924949ELISA-DOXA SCL-702Cleared 510(K)
- K924945ELISA-DPXA SSA KIT2Cleared 510(K)
- K924946ELISA-DOXA SSB2Cleared 510(K)
- K924947ELISA-DOXA SM2Cleared 510(K)
- K924948ELISA-DOXA SM/RNP2Cleared 510(K)
- K924950ELISA-DOXA JO-12Cleared 510(K)
- K924951ELISA-DOXA COMBI-42Cleared 510(K)
- K924952ELISA-DOXA COMBI-62Cleared 510(K)
- K930417SYNELISA SCL-70 ANTIBODIES2Cleared 510(K)
- K930281SYNELISA JO-1 ANTIBODIES2Cleared 510(K)
- K930757RHEUMELISA II JO-1 ANTIBODY TEST KIT2Cleared 510(K)
- K930130RHEUMELISA II SCL-70 ANTIBODY TEST KIT2Cleared 510(K)
- K926562QUANTA LITE(TM) JO-1 ELISA KIT2Cleared 510(K)
- K925118EN TYPING CIE KIT FOR DIAGNOSTIC USE2Cleared 510(K)
- K924262ENA SCREENING CIE KIT FOR DIAGNOSTIC USE2Cleared 510(K)
- K924898QUANTA LITE(TM) SCL-70 ELISA2Cleared 510(K)
- K924843IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL2Cleared 510(K)
- K921870ENCORE SM/RNP2Cleared 510(K)
- K921572ENCORE SM2Cleared 510(K)
- K922241AUTOZYME2Cleared 510(K)
- K922340ENCORE SS-B2Cleared 510(K)
- K922157ENCORE SS-A2Cleared 510(K)
- K922830QUANTA LITE SS-A ELISA2Cleared 510(K)
- K922833QUANTA LITE RNP ELISA2Cleared 510(K)
- K922832QUANTA LITE SS-B ELISA2Cleared 510(K)
- K922831QUANTA LITE SM ELISA2Cleared 510(K)
- K922829QUANTA LITE ENA ELISA2Cleared 510(K)
- K915420HEMAGEN ENA [JO-1] KIT (EIA METHOD)2Cleared 510(K)
- K920386ANTI-ENA ANTIBODY TEST KIT2Cleared 510(K)
- K920385ANTI-ENA ANTIBODY TEST (SM)2Cleared 510(K)
- K920384ANIT-ENA ANTIBODY TEST [SS-B (LA)]2Cleared 510(K)
- K920383ANTI-ENA ANTIBODY TEST [SS-A (RO)]2Cleared 510(K)
- K915282HEMAGEN ENA SCL-70 KIT (EIA METHOD)2Cleared 510(K)
- K915234HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)2Cleared 510(K)
- K915058HEMAGEN ENA SCREENING KIT (EIA METHOD)2Cleared 510(K)
- K913041ANTI-DSDNA ANTIBODY TEST2Cleared 510(K)
- K911679ANTI-JO-1 MICROASSAY2Cleared 510(K)
- K910232HEMAGEN ENA SCREENING KIT2Cleared 510(K)
- K903898QUANTA LITE TM DSDNA2Cleared 510(K)
- K903314ANTI-SCI-70 ANTIBODY TEST2Cleared 510(K)
- K903047IMMUMODOT AUTOIMMUNITY SCREENING PANEL 42Cleared 510(K)
- K902938IMMUNODOT AUTOIMMUNITY SCREENING PANEL 32Cleared 510(K)
- K901924READS(R) ANTI-ENA (SM/RNP) TEST KIT2Cleared 510(K)
- K901230REAADS ANTI-SM TEST KIT2Cleared 510(K)
- K901073ANTI-RNP MICROASSAY2Cleared 510(K)
- K900617SERATEST ENA [SSA] KIT2Cleared 510(K)
- K900241ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY2Cleared 510(K)
- K896462NOVA GEL(TM) T JO-12Cleared 510(K)
- K896461NOVA GEL(TM) T SCL-702Cleared 510(K)
- K896460NOVA GEL(TM) T SS-A/SS-B2Cleared 510(K)
- K896459NOVA GEL(TM) T SM/RNP2Cleared 510(K)
- K895339ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST2Cleared 510(K)
- K892897NOVA GEL(TM) JO-12Cleared 510(K)
- K881341NOVA LITE(TM) SA2Cleared 510(K)
- K883232HISTONE REACTIVE ANA2Cleared 510(K)
- K881340NOVA LITE(TM) AUTOANTIBODY CONTROLS2Cleared 510(K)
- K881339NOVA LITE(TM) ANA PLUS2Cleared 510(K)
- K880897NOVA GEL (TM) SCL-702Cleared 510(K)
- K881181NOVA GEL(TM) SM/RNP2Cleared 510(K)
- K880896NOVA GEL(TM) SS-A/SS-B2Cleared 510(K)
- K880736NOVA LITE(TM) ANA2Cleared 510(K)
- K873708FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES2Cleared 510(K)
- K871994ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)2Cleared 510(K)
- K862700SERATEST ENA [SS-B] KIT2Cleared 510(K)
- K862710KALLESTAD SSA/SSB ENA TEST REAGENTS2Cleared 510(K)
- K860428SM-RNP AUTOANTIBODY TEST SYSTEM2Cleared 510(K)
- K860644SS-A/SS-B AUTOANTIBODY TEST SYSTEM2Cleared 510(K)
- K843423PHYSIO GAS ANALYZER2Cleared 510(K)
- K844743SERATEST ENA(RNP/SM) DETERMINATION2Cleared 510(K)
- K843978ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY2Cleared 510(K)
- K840221EXTRACTABLE NUCLEAR ANTIGEN ASSAY2Cleared 510(K)
- K831036ENA TEST KIT SM & RNP AUTO ANTIBODY2Cleared 510(K)
- K810592NUCLEAR ANTIGENS2Cleared 510(K)
- 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
ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K931495
- 510(k) Type
- Traditional
- Applicant
- HELIX DIAGNOSTICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/16/1993
- Days to Decision
- 113 days
- Submission Type
- Statement