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
- K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay2Cleared 510(K)
- K151559ImmuLisa Enhanced Centromere Antibody ELISA2Cleared 510(K)
- K140493ELIA SCL-70S IMMUNOASSAY2Cleared 510(K)
- K123880QUANTA FLASH CENTROMERE2Cleared 510(K)
- K131330GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT2Cleared 510(K)
- K131185ANA SCREEN ELISA (IGG)2Cleared 510(K)
- K083188VARELISA RECOMBI ANA SCREEN, MODEL 12 5962Cleared 510(K)
- K050967VARELISA RECOMBI CTD SCREEN, MODEL 130962Cleared 510(K)
- K050625VARELISA RECOMBI ANA PROFILE, MODEL 184962Cleared 510(K)
- K041102IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA2Cleared 510(K)
- K040953AESKULISA ANA HEP-22Cleared 510(K)
- K040810VARELISA HISTONE ANTIBODIES, MODEL 164962Cleared 510(K)
- K040291EL-ANA PROFILES: ANTI-CHROMATIN2Cleared 510(K)
- K040200MESACUP-2 TEST CENP-B2Cleared 510(K)
- K030929ANA DETECT2Cleared 510(K)
- K024031THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE2Cleared 510(K)
- K022018RHIGENE ANA ELISA TEST SYSTEM, MODEL K75602Cleared 510(K)
- K004019ANA EIA DIAGNOSTIC TEST KIT2Cleared 510(K)
- K003959QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA2Cleared 510(K)
- K002559EL-ANA PROFILES-2K12Cleared 510(K)
- K000879THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE2Cleared 510(K)
- K000880THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE2Cleared 510(K)
- K000934MDI SCL-70 TEST2Cleared 510(K)
- K994071RHIGENE ANA ELISA TEST SYSTEM2Cleared 510(K)
- K993635MDI SM/RNP TEST2Cleared 510(K)
- K993636MDI SS-A TEST2Cleared 510(K)
- K993108VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 962Cleared 510(K)
- K993109VARELISA RECOMBI ANA PROFILE2Cleared 510(K)
- K992041RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-112Cleared 510(K)
- K983655AUTOSTAT II ANA SCREEN ELISA2Cleared 510(K)
- K983378THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.2Cleared 510(K)
- K980810SERAQUEST ANTI-SSA2Cleared 510(K)
- K980337DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM2Cleared 510(K)
- K964385ELIAS ANA-HEP-22Cleared 510(K)
- K962450HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE2Cleared 510(K)
- K962062ORGENTEC ANTI-SM ELISA2Cleared 510(K)
- K962057ORGENTEC ANTI-RNP/SM ELISA2Cleared 510(K)
- K962054ORGENTEC ANTI-SS-A(RO) ELISA2Cleared 510(K)
- K962053ORGENTEC ANTI-JO-1 ELISA2Cleared 510(K)
- K962055ORGENTEC ANTI-SCL 70 ELISA2Cleared 510(K)
- K962052ORGENTEC ABTI-SS-BB(LA) ELISA2Cleared 510(K)
- K963291VARELISA ANA (4) PROFILE2Cleared 510(K)
- K954829ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY2Cleared 510(K)
- K954832ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY2Cleared 510(K)
- K954814ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY2Cleared 510(K)
- K954815ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY2Cleared 510(K)
- K955481THERATEST KIT (MODIFICATION)2Cleared 510(K)
- K954380QUANTA LITE SSDNA2Cleared 510(K)
- K952490IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM2Cleared 510(K)
- K954106THERATEST LAB, INC., EL-ANASCR KIT2Cleared 510(K)
- K950716THERATEST EL-ANA PROFILES TEST SYSTEM2Cleared 510(K)
- K951850ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT2Cleared 510(K)
- K951798ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT2Cleared 510(K)
- K950110MARDX MITOCHONDRIA EIA TEST SYSTEM2Cleared 510(K)
- K946218MARDX ENA EIA TEST SYSTEM2Cleared 510(K)
- K951205VARELISA ANA PROFILE2Cleared 510(K)
- K951207VARELISA HISTONE ANTIBODIES2Cleared 510(K)
- K951186VARELISA ANA-4 SCREEN2Cleared 510(K)
- K943585ANTI-HISTONE ANIBODY TEST2Cleared 510(K)
- K944173VARELISA JO-1 ANTIBODIES2Cleared 510(K)
- K944172VARELISA SCL-70 ANTIBODIES2Cleared 510(K)
- K944171VARELISA CENTROMERE ANTIBODIES2Cleared 510(K)
- K944170VARELISA SM ANTIBODIES2Cleared 510(K)
- K944169VARELISA RO (SS-A) ANTIBODIES2Cleared 510(K)
- K944168VARELISA LA (SS-B) ANTIBODIES2Cleared 510(K)
- K944167VARELISA RNP-SM ANTIBODIES2Cleared 510(K)
- K941509RADIAS ANA SCREEN ENZYME IMMUNOASSAY2Cleared 510(K)
- K941409ENA PROFILE-6 ELISA TEST SYSTEM2Cleared 510(K)
- K941014ENA SCREEN ELISA TEST SYSTEM2Cleared 510(K)
- K940700AUTOZYME SCREEN2Cleared 510(K)
- K940253HISTONE EIA TEST KIT2Cleared 510(K)
- K935415RNP EIA TEST KIT2Cleared 510(K)
- K935416RO EIA TEST KIT2Cleared 510(K)
- K935414SM EIA TEST KIT2Cleared 510(K)
- K940641ELIAS ANA TOTAL2Cleared 510(K)
- K935468SYNELISA ANA TOTAL2Cleared 510(K)
- K933267AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM2Cleared 510(K)
- K932206SYNELISA ANA PROFILE2Cleared 510(K)
- K932424ANA PROFILE I2Cleared 510(K)
- K930209SYNELISA RO ABS / LA ABS2Cleared 510(K)
- K924248ACCUTEX SLE LATEX TEST2Cleared 510(K)
- K924087KALESTAD ANA MICROPLATE EIA2Cleared 510(K)
- K920616DIASTAT ANTI-HISTONE KIT2Cleared 510(K)
- K915272HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)2Cleared 510(K)
- K914853ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT2Cleared 510(K)
- K910033UBI MAGIWEL(TM) ANA QUANTITATIVE2Cleared 510(K)
- K905190DIASTAT ENA PROFILE2Cleared 510(K)
- K902915ANTI-SCI-70 MICROASSAY2Cleared 510(K)
- K900072IMMUNODOT AUTOIMMUNITY SCREENING PANEL 22Cleared 510(K)
- K896347IMMUNODOT AUTOIMMUNE SCREENING PANEL 12Cleared 510(K)
- K895995RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES2Cleared 510(K)
- K895994RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES2Cleared 510(K)
- K894894ANTI-SM MICROASSAY2Cleared 510(K)
- K892421MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST2Cleared 510(K)
- K874195LA ANTIBODY TEST KIT2Cleared 510(K)
- K875246LIPOGEN ANA TEST KIT2Cleared 510(K)
- K872839ANTINUCLEAR ANTIBODY TEST2Cleared 510(K)
- K870453DS-DNA EIA DIAGNOSTIC KIT2Cleared 510(K)
- K870452SS-DNA EIA DIAGNOSTIC KIT2Cleared 510(K)
- K870457RNP EIA DIAGNOSTIC KIT2Cleared 510(K)
- K870456DNP EIA DIAGNOSTIC KIT2Cleared 510(K)
- K870455SM EIA DIAGNOSTIC KIT2Cleared 510(K)
- K862969ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT2Cleared 510(K)
- K852840ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST2Cleared 510(K)
- K852231ANA/LITE-HEP-2 TEST SYSTEM2Cleared 510(K)
- K852230ANA/LITE-RL TEST SYSTEM2Cleared 510(K)
- K843904DNA STAT TEST KIT2Cleared 510(K)
- K843745ADP ANA APPLEZYME2Cleared 510(K)
- K842533AMIZYME-ANDNA TEST KIT2Cleared 510(K)
- K842532AMIZYME-ANA TEST KIT2Cleared 510(K)
- K833148ENZYME ANA TEST SYSTEM2Cleared 510(K)
- K822346HISTIMUNE ENZYME-ANA TEST2Cleared 510(K)
- 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
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K980337
- 510(k) Type
- Traditional
- Applicant
- HELIX DIAGNOSTICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/12/1998
- Days to Decision
- 104 days
- Submission Type
- Statement