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
- K231151Kenota 1 Total IgE; Kenota 1 (instrument)2Cleared 510(K)
- K214068Quantia IgE2Cleared 510(K)
- K220178Total Immunoglobulin E (IgE)2Cleared 510(K)
- K193493ADVIA Centaur Total IgE (tIgE)2Cleared 510(K)
- K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls2Cleared 510(K)
- K133404IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH2Cleared 510(K)
- K063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH2Cleared 510(K)
- K050493QUANTIA IGE2Cleared 510(K)
- K042241K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C2Cleared 510(K)
- K034057LACRYTEST2Cleared 510(K)
- K032251IMMUNETECH TOTAL IGE SYSTEM2Cleared 510(K)
- K024210IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR2Cleared 510(K)
- K010855RANDOX IGE2Cleared 510(K)
- K002560SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT2Cleared 510(K)
- K992528BIOCHECK IGE ELISA, MODEL BC-10352Cleared 510(K)
- K991316TOUCH TEAR IGE MICROASSAY KIT2Cleared 510(K)
- K991945PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-012Cleared 510(K)
- K991787N LATEX IGE MONO REAGENT2Cleared 510(K)
- K983185BOEHRINGER MANNHEIM TINA-QUANT IGE TEST2Cleared 510(K)
- K972697AIA-PACK IGE II ASSAY2Cleared 510(K)
- K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH2Cleared 510(K)
- K940183HY-TEC TOTAL IGE ENZYME IMMUNOASSAY2Cleared 510(K)
- K934594MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM2Cleared 510(K)
- K933180QUANTA LITE MITOCHONDRIA M2 ELISA2Cleared 510(K)
- K930890COBAS(R) CORE IGE TOTAL EIA2Cleared 510(K)
- K930984ACCESS(R) TOTAL IGE ASSAY2Cleared 510(K)
- K923832PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION2Cleared 510(K)
- K922047IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF40642Cleared 510(K)
- K920372ACS TOTAL IGE IMMUNOASSAY2Cleared 510(K)
- K912800KALLESTEAD TOTAL IGE MICROPLATE KIT2Cleared 510(K)
- K910419BIOCLONE'S ELEGANCE IGE ELISA KIT2Cleared 510(K)
- K911631PHARMACIA SPECIFIC IGE CONTROL2Cleared 510(K)
- K910082POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK2Cleared 510(K)
- K905612VENTREX COATED TUBE IGE RADIOIMMUNOASSAY2Cleared 510(K)
- K903738QUIDEL ALLERGEN SCREEN POSITIVE CONTROL2Cleared 510(K)
- K903195LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY2Cleared 510(K)
- K9002443M MULTI-ALLERGEN IGE FASTSCREEN(TM) S82Cleared 510(K)
- K9001083M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,122Cleared 510(K)
- K895914ABBOTT IMX IGE2Cleared 510(K)
- K895004MILENIA(TM) TOTAL IGE (MKIE1,5)2Cleared 510(K)
- K895294PROGENE IGE BEAD EIA2Cleared 510(K)
- K893951PHARMACIA CAP SYSTEM IGE RIA AND FEIA2Cleared 510(K)
- K892197ALATOP (TM) CATALOG # AKAL12Cleared 510(K)
- K890530N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)2Cleared 510(K)
- K885307FLIPSCREEN (TM) TOTAL E IMMUNOASSAY2Cleared 510(K)
- K884545DELFIA (TM) HIGE KIT2Cleared 510(K)
- K882625PHARMACIA IGE RIA ULTRA2Cleared 510(K)
- K882626PHARMACIA IGE EIA ULTRA2Cleared 510(K)
- K881892PHARMACIA IGE RIACT2Cleared 510(K)
- K874541RRT TOTAL IGE TEST KIT2Cleared 510(K)
- K874406IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-10642Cleared 510(K)
- K872913ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,52Cleared 510(K)
- K872968ULTRASCAN IGE ASSAY KIT2Cleared 510(K)
- K864142UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE2Cleared 510(K)
- K863858TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--2Cleared 510(K)
- K863822ENZYMUN-TEST(R) IGE2Cleared 510(K)
- K862174TIMOTHY ALLERGEN DISC2Cleared 510(K)
- K862368AMPLIFIED ELISA IGE KIT2Cleared 510(K)
- K861171QUIDEL ALLERGY SCREEN2Cleared 510(K)
- K860032TOTAL IGE-IRMA RIA KIT2Cleared 510(K)
- K860033EIA MONOCLONAL TOTAL IGE KIT2Cleared 510(K)
- K852878THE DPC MONOCLONAL EIA TOTAL IGE KIT2Cleared 510(K)
- K853025IMAGE-IGE2Cleared 510(K)
- K852268QUANTICLONE IGE RADIOIMMUNASSAY2Cleared 510(K)
- K851156PHARMACIA IGE RIA MODIFIED2Cleared 510(K)
- K850786TOTAL HIGE ENZYME IMMUNOASSAY2Cleared 510(K)
- K843369AGGLUTINATION TEST FOR TOTAL IGE2Cleared 510(K)
- K843710ELISA FOR TOTAL IGE2Cleared 510(K)
- K843408ENCORE IGE REAGENT2Cleared 510(K)
- K842125ALLERCOAT ALLERGEN DISCS2Cleared 510(K)
- K841829PHADEBAS RAST PHADEZYM RAST ALLERGEN2Cleared 510(K)
- K841824PHARMACIA IGE RIA2Cleared 510(K)
- K841642MAST LUMINESCENT ALLERGY SYS2Cleared 510(K)
- K841651VAST VENTREX RAST ALL2Cleared 510(K)
- K840476PHADEXACT SERUM, TOTAL IGE CONTROLS2Cleared 510(K)
- K840674SENSIBEAD EIA IGE KIT2Cleared 510(K)
- K840538PHADEXACT SERUM, ALLERGEN SPECIFIC IGE2Cleared 510(K)
- K834594TOTAL IGE FAST TEST2Cleared 510(K)
- K833419LABELED 125I ANTI-IGE2Cleared 510(K)
- K833969MAST TOTAL IGE2Cleared 510(K)
- K832345POLYSTYRENE MICROTITER WELL IMMUNOSOR2Cleared 510(K)
- K832360ABBOTT IGE EIA2Cleared 510(K)
- K832218ALLERGEN CONTROL INHALENT2Cleared 510(K)
- K831485VENTRE/ZYME IGE KIT2Cleared 510(K)
- K831377IGE RADIOIMMUNOASSAY KIT2Cleared 510(K)
- K831326ALLERCOAT ALLERGEN DISCS2Cleared 510(K)
- K831208IGE-QUANT DIAGNOSTIC TEST KIT2Cleared 510(K)
- K830817NEW ALLERGEN DISCS FOR USE IN VAST VENT2Cleared 510(K)
- K830357RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E2Cleared 510(K)
- K830164DENSITOMETRIC INHALENT PROFILE SLLER2Cleared 510(K)
- K823494TOTAL IGE-FAST TEST2Cleared 510(K)
- K823842PHADEZYM RAST ALLERGEN DISCS2Cleared 510(K)
- K823841PHADEBAS RAST ALLERGEN DISCS2Cleared 510(K)
- K823507TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY2Cleared 510(K)
- K823403ALLERCOAT POSITIVE CONTROL SERUM2Cleared 510(K)
- K822341ALLERGENETICS IGE-FAST TEST2Cleared 510(K)
- K822613RAST ALLERCOAT ALLERGEN DISCS2Cleared 510(K)
- K822442VAST VENTREX RAST ALLERGEN DISCS2Cleared 510(K)
- K822206TOTAL IGE DISCS2Cleared 510(K)
- K821092GAMMADAB[125]EGE RADIOIMMUNOASSAY IT2Cleared 510(K)
- K820978VENTRE/SPEC ALLERGEN CONTROL-INHALANT2Cleared 510(K)
- K820977VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD2Cleared 510(K)
- K821615VAST VENTREX PD IGE RIA TEST SET2Cleared 510(K)
- K820897VENTRE/SPEC IGE CONTROLS2Cleared 510(K)
- K820896VENTREX 125I ANTI-IGE ALLERGY ISOTOPE2Cleared 510(K)
- K813189PHADEBAS/PHADEZYM IGE REAGENTS2Cleared 510(K)
- K811559VENTRE/SEP IGE RIA TEST SET2Cleared 510(K)
- K811545KALLESTAD QUANTITOPE LOW LEVEL IGE REAG2Cleared 510(K)
- K802913TAN DEM* - IGE KIT2Cleared 510(K)
- K810507PHADEZYM IGE PRIST TEST2Cleared 510(K)
- K801019125I-IGE RADIOIMMUNOASSAY KIT2Cleared 510(K)
- K781904RIA KIT, QUANTITOPE IGE2Cleared 510(K)
- K780753LAS-R HUMAN IGE TEST2Cleared 510(K)
- K771238RID PLATES & INTENSI. FOR HUMAN IGE ETC2Cleared 510(K)
- 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
- 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
RANDOX IGE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K010855
- 510(k) Type
- Traditional
- Applicant
- RANDOX LABORATORIES, LTD.
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/15/2001
- Days to Decision
- 54 days
- Submission Type
- Statement