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
- K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFine2Cleared 510(K)
- K172745ImmuGlo HEp-2 Elite IFA2Cleared 510(K)
- K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM2Cleared 510(K)
- K160265Image Navigator by Immuno Concepts2Cleared 510(K)
- K141827EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE2Cleared 510(K)
- K150155NOVA Lite DAPI ANA Kit2Cleared 510(K)
- K131791IFA 40: HEP-20-102Cleared 510(K)
- K120889AESKUSLIDES ANA HEP-22Cleared 510(K)
- K070763EUROIMMUN ANA IFA: HEP-20-102Cleared 510(K)
- K042680RHIGENE HEP-ANA TEST SYSTEM2Cleared 510(K)
- K024220LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #1302Cleared 510(K)
- K024227LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #1272Cleared 510(K)
- K024229LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #1112Cleared 510(K)
- K024230LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #1312Cleared 510(K)
- K024225LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #1192Cleared 510(K)
- K024217LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #1082Cleared 510(K)
- K024221LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #1182Cleared 510(K)
- K024222LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #1122Cleared 510(K)
- K024224LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #1292Cleared 510(K)
- K024231LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #1182Cleared 510(K)
- K022800VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM2Cleared 510(K)
- K013213HYPERION VISIQUANT ANA TEST KIT2Cleared 510(K)
- K012163POLYTITER SYSTEM2Cleared 510(K)
- K001556HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY2Cleared 510(K)
- K990915INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY2Cleared 510(K)
- K984397LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 2032Cleared 510(K)
- K984400LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 2022Cleared 510(K)
- K984399LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 2042Cleared 510(K)
- K984398LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 2012Cleared 510(K)
- K983924HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO2Cleared 510(K)
- K972145HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM2Cleared 510(K)
- K970198IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES2Cleared 510(K)
- K964165MICRO21 WITH NDNA2Cleared 510(K)
- K962276HEMAGEN ENA DSDNA KIT (EIA METHOD)2Cleared 510(K)
- K950979HEP-2000 COLORZYME ANA-RO TEST SYSTEM2Cleared 510(K)
- K944096HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM2Cleared 510(K)
- K926114HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM2Cleared 510(K)
- K912292DIASTAT ANTI-JO-1 KIT2Cleared 510(K)
- K902139HEMAGEN ENA [JO-I] KIT2Cleared 510(K)
- K901596NOVA LITE(TM) ANA KSL2Cleared 510(K)
- K901595NOVA LITE(TM) ANA MK2Cleared 510(K)
- K897025ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM2Cleared 510(K)
- K894659ANA ANTISERA CONTROL KIT2Cleared 510(K)
- K884400ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)2Cleared 510(K)
- K880742NOVA LITE(TM) DSDNA2Cleared 510(K)
- K874873COMBIGENE(TM) ANTI-DNA #KADDZ, KADD12Cleared 510(K)
- K872845BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM2Cleared 510(K)
- K872560ANTI-DNP MICROASSAY2Cleared 510(K)
- K871801CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT2Cleared 510(K)
- K871144TANGENT SYSTEM(TM) ANA PROFILE TEST KIT2Cleared 510(K)
- K871395DUAL SUBSTRATE ANA2Cleared 510(K)
- K870458HISTONES EIA DIAGNOSTIC KIT2Cleared 510(K)
- K870732RAT LIVER NUCLEI TEST SYSTEM2Cleared 510(K)
- K863717ANTI-DNA MICROASSAY2Cleared 510(K)
- K862821CAPPEL DIAGNOSTICS ANA KIT2Cleared 510(K)
- K860183AFT-HEP SYSTEM2Cleared 510(K)
- K854314FANA 602Cleared 510(K)
- K852033SS-A(RO) & SS-B(LA) ANTIBODY ASSAY2Cleared 510(K)
- K851369ANTINUCLEAR ANTIBODY TEST KIT2Cleared 510(K)
- K842991AUTOFLUOR V SYSTEM2Cleared 510(K)
- K844678MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL2Cleared 510(K)
- K843225COLORZYME NDNA TEST SYSTEM2Cleared 510(K)
- K841984AUTOFLOUR III SYSTEM2Cleared 510(K)
- K843347RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON2Cleared 510(K)
- K842183ADP ANA IFA TEST2Cleared 510(K)
- K841776ANA SENSITIVITY/SPECIFICITY CONTROL2Cleared 510(K)
- K841127VIRGO REAGENTS INDIRECT FLUORSCENT2Cleared 510(K)
- K834241ANA APPLELISA2Cleared 510(K)
- K833119AUTOIMMUNE TEST 1/2/3 SYSTEM2Cleared 510(K)
- K832383IDT ANA STIQ ASSAY2Cleared 510(K)
- K831408DNA FLOR2Cleared 510(K)
- K831054ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB2Cleared 510(K)
- K830214AFT SYSTEM III2Cleared 510(K)
- K822681ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)2Cleared 510(K)
- K822682ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K2Cleared 510(K)
- K823055FLOUROSET IMMUNOFLUORESCENT ANTIBODY2Cleared 510(K)
- K820945SERA FOR ANTINUCLEAR ANTIBODIES2Cleared 510(K)
- K822397ANA HEP-2 FLUORO-KIT2Cleared 510(K)
- K822607ANTINUCLEAR ANTOBODY CELL SUBSTRATE2Cleared 510(K)
- K820265ANA TEST (MOUSE LIVER SUBSTRATE)2Cleared 510(K)
- K813592QUANTAFLUOR FLUORESCENT TEST REAGENTS2Cleared 510(K)
- K812314CRITHIDNA ANTI-DNA TEST KIT2Cleared 510(K)
- K811714HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT2Cleared 510(K)
- K810985ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT2Cleared 510(K)
- K811022ANA TEST KIT2Cleared 510(K)
- K810301CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST2Cleared 510(K)
- K810081SCRIPPSERA ANA REFERENCE CONTROL SERA2Cleared 510(K)
- K802299K/K (ASMA/ANA) UNIVERSAL BIOPAK2Cleared 510(K)
- K803276ANA-IFA TEST SYSTEM2Cleared 510(K)
- K802527TEST KIT FOR DETECTION OF ANTINUCLEAR2Cleared 510(K)
- K801046ANATON2Cleared 510(K)
- K792184LAB-TEK ANA TEST KIT2Cleared 510(K)
- K791928ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT2Cleared 510(K)
- K791995ANTI NUCLEAR ANTIBODY TEST2Cleared 510(K)
- K791493ANTI-NUCLEAR ANTIBODY TEST2Cleared 510(K)
- K790280AUTOANTIBODY REAGENTS, AFT SYSTEM II2Cleared 510(K)
- K790252ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI2Cleared 510(K)
- K782048TEST KIT, IIF-ANA2Cleared 510(K)
- K782041FIAX TEST KIT2Cleared 510(K)
- K780899FLUORESCENT ANTI-NATIVE DNA TEST2Cleared 510(K)
- K780178TEST SYS. FOR NDNA ANTIBODY DETERM.2Cleared 510(K)
- K780161IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER2Cleared 510(K)
- K772219FIAX TEST FOR ANTI-RUBELLA ANTIBODY2Cleared 510(K)
- K771376IFA ANTI-NDNA2Cleared 510(K)
- K771064ANA TEST2Cleared 510(K)
- K770057NDNA IMMUNOPATH FLUORO-KIT2Cleared 510(K)
- K760681INDIRECT FLUORESCENT (IFA-ANA)2Cleared 510(K)
- K760206TEST, DETECTION, ANTINUCLEAR ANTIBODIES2Cleared 510(K)
- K760209ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP2Cleared 510(K)
- K760153TEST, (IVDP) ANTINUCLEAR ANTIBODY2Cleared 510(K)
- 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
- 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
- OYVInherited Nucleotide Repeat Disorder Dna Test2Product 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
- PGVAnti-Phospholipase A2 Receptor2Product Code
- QUKHuman Leukocyte Antigen (Hla) Typing Companion Diagnostic Test2Product Code
- SGGMass Spectrometric, Immunoglobulins (G, A, M, D, E)2Product 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
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K970198
- 510(k) Type
- Traditional
- Applicant
- Scimedx Corp.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/20/1997
- Days to Decision
- 30 days
- Submission Type
- Statement