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
- K252775NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg2Cleared 510(K)
- K252493NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)2Cleared 510(K)
- K242531NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz2Cleared 510(K)
- K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed2Cleared 510(K)
- K220162Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria2Cleared 510(K)
- K193613Allergen-Specific IgE Assay 12 Allergen Bundle2Cleared 510(K)
- K200825NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense2Cleared 510(K)
- K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine2Cleared 510(K)
- K191510Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae2Cleared 510(K)
- K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat2Cleared 510(K)
- K182793AP3600 Automated Instrument2Cleared 510(K)
- K182479NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus2Cleared 510(K)
- K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut2Cleared 510(K)
- K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE2Cleared 510(K)
- K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite2Cleared 510(K)
- K151029Phadia Prime2Cleared 510(K)
- K150854ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut2Cleared 510(K)
- K132801IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY2Cleared 510(K)
- K122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES2Cleared 510(K)
- K131738IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H2Cleared 510(K)
- K123275IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM2Cleared 510(K)
- K121156AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES2Cleared 510(K)
- K121463IMMUNOCAP ALLERGEN K822Cleared 510(K)
- K112910AP 72OS SEMI-AUTOMATED INSTRUMENT2Cleared 510(K)
- K113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLE2Cleared 510(K)
- K112523IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT2Cleared 510(K)
- K111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS2Cleared 510(K)
- K101572IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT2Cleared 510(K)
- K101251IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN2Cleared 510(K)
- K100910IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN62Cleared 510(K)
- K093987IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN62Cleared 510(K)
- K100999IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-012Cleared 510(K)
- K093107IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT2Cleared 510(K)
- K092978IMMUNOCAP RAPID READER, MODEL 12-3600-102Cleared 510(K)
- K092050IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-012Cleared 510(K)
- K091984IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN62Cleared 510(K)
- K091289IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT2Cleared 510(K)
- K090257IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT2Cleared 510(K)
- K083853IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT2Cleared 510(K)
- K081830IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC12Cleared 510(K)
- K083314IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT2Cleared 510(K)
- K081217HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM2Cleared 510(K)
- K080322HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 2002Cleared 510(K)
- K071913IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-012Cleared 510(K)
- K051677OPTIGEN ALLERGEN SPECIFIC IGE ASSAY2Cleared 510(K)
- K051218MODIFICATION TO: UNICAP SPECIFIC IGE2Cleared 510(K)
- K030590CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)2Cleared 510(K)
- K023152IMMULITE 2000 ALLERGEN-SPECIFIC IGE2Cleared 510(K)
- K021208IMMULITE 2000 MIXED ALLERGEN PANELS2Cleared 510(K)
- K021206IMMULITE 2000 SPECIFIC ALLERGENS2Cleared 510(K)
- K020387MYALLERGYTEST SYSTEM2Cleared 510(K)
- K013135IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)2Cleared 510(K)
- K013134IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)2Cleared 510(K)
- K000132ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K82Cleared 510(K)
- K993388ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F2Cleared 510(K)
- K991048ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F22Cleared 510(K)
- K983954ALASTAT MICROPLATE MIXED ALLERGEN PANELS2Cleared 510(K)
- K982343ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,32Cleared 510(K)
- K974580ALLERGEN IMMUNOCAP F256,F245,F207,F2022Cleared 510(K)
- K974350ALLERGAN IMMUNO CAP M4, M8, K702Cleared 510(K)
- K973186IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE2Cleared 510(K)
- K972364UNICAP PHADIATOP2Cleared 510(K)
- K972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K822Cleared 510(K)
- K965094HYCOR ALLERGEN DISC2Cleared 510(K)
- K962976PHARMACIA CAP SYSTEM RAST FEIA2Cleared 510(K)
- K963245IMMULITE LATEX-SPECIFIC IGE2Cleared 510(K)
- K961889SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS2Cleared 510(K)
- K962274UNICAP 1002Cleared 510(K)
- K941993PHARMACIA CAP SYSTEM PHADIATOP FEIA2Cleared 510(K)
- K954566SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM2Cleared 510(K)
- K953780ACCESS ALLERGEN DOG EPITHELIM2Cleared 510(K)
- K950728QUICKVUE ONE-STEP ALLERGEN SCREEN2Cleared 510(K)
- K953014ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN2Cleared 510(K)
- K945884SPECIFIC IGE ULTRA-EIA2Cleared 510(K)
- K945748HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY2Cleared 510(K)
- K950629ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR2Cleared 510(K)
- K931746LATEX (K82)2Cleared 510(K)
- K941278HY-TEC AUTOMATED EIA SYSTEM2Cleared 510(K)
- K943768HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT2Cleared 510(K)
- K941057SPECIFIC IGE EIA-ULTRA ASSAY2Cleared 510(K)
- K941564IMMULITE ALATOP ALLERGY SCREEN2Cleared 510(K)
- K935488ALATOP(R) MICROPLATE ALLERGY SCREEN2Cleared 510(K)
- K935876ACCESS SPECIFIC IGE ASSAY2Cleared 510(K)
- K934524MAST CLA ALLERGY SYSTEM2Cleared 510(K)
- K926420MAST CLA ALLERGY SYSTEM2Cleared 510(K)
- K925044VENTREX ALLERGEN DISC2Cleared 510(K)
- K923420CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY2Cleared 510(K)
- K925425SPECIFIC IGE EIA-TURBO ASSAY2Cleared 510(K)
- K924044VENTREX ALLERGEN DISC2Cleared 510(K)
- K924209VENTREX ALLERGEN DISC2Cleared 510(K)
- K924119VENTREX ALLERGEN DISC2Cleared 510(K)
- K923284BASELINE CALIBRATION VERIFICATION CONTROLS2Cleared 510(K)
- K914685866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS2Cleared 510(K)
- K914959MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM2Cleared 510(K)
- K921574WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC2Cleared 510(K)
- K922538VENTREX ALLERGEN DISC2Cleared 510(K)
- K914554SPECIFIC IGE EIA-TURBO ASSAY2Cleared 510(K)
- K913833VENTREX ALLERGEN DISC2Cleared 510(K)
- K914850CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE2Cleared 510(K)
- K913150ABBOTT MATRIX AERO PLUS SYSTEM2Cleared 510(K)
- K9132123M IGE SINGLE POINT FAST TEST2Cleared 510(K)
- K912294ALLERGY INFORMATION MANAGER2Cleared 510(K)
- K913892FASTTECH SYSTEM II2Cleared 510(K)
- K911903ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA2Cleared 510(K)
- K912582MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM2Cleared 510(K)
- K894227ALLERGEN MODULES FOR ALASTAT TM2Cleared 510(K)
- K910292MAST CLA ALLERGY SYSTEM2Cleared 510(K)
- K905054CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER2Cleared 510(K)
- K910517CAP SYSTEM RAST ASM/RIA AND ASM/FEIA2Cleared 510(K)
- K905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY2Cleared 510(K)
- K910075SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE2Cleared 510(K)
- K905162QUIDEL TOTAL IGE POSITIVE CONTROL SERUM2Cleared 510(K)
- K905176POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN2Cleared 510(K)
- K904330TURBO-RAST SPECIFIC IGE ASSAY2Cleared 510(K)
- K904661IVT RAST TRACER2Cleared 510(K)
- K903637ALRGN SET2Cleared 510(K)
- K903742ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE2Cleared 510(K)
- K902576ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA2Cleared 510(K)
- K894190PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA2Cleared 510(K)
- K8971453M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8)2Cleared 510(K)
- K896902ENZYMUN TEST R IGE2Cleared 510(K)
- K896852VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY2Cleared 510(K)
- K896694VENTREZYME VAST SPECIFIC IGE ASSAY2Cleared 510(K)
- K896592CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY2Cleared 510(K)
- K894253QUIDEL FOOD ALLERGEN SCREEN2Cleared 510(K)
- K893132PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC2Cleared 510(K)
- K891135PHADIATOP PAEDIATRIC RIA AND EIA2Cleared 510(K)
- K892409QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN2Cleared 510(K)
- K884501QUIDEL FOOD ALLERGY SCREEN2Cleared 510(K)
- K885269ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS2Cleared 510(K)
- K88488328 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM)2Cleared 510(K)
- K884923MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM)2Cleared 510(K)
- K885065IGE FASTSCREEN S6 (F1, F2, F4, F13, F14)2Cleared 510(K)
- K883537QM300 CONTROL E2Cleared 510(K)
- K884185CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY2Cleared 510(K)
- K883371MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10)2Cleared 510(K)
- K883666QUIDEL ALLERGY SCREEN2Cleared 510(K)
- K883616SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)2Cleared 510(K)
- K883273DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)2Cleared 510(K)
- K881899SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.2Cleared 510(K)
- K875110HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC2Cleared 510(K)
- K880899PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA2Cleared 510(K)
- K880221INCSTAR'S PIGWEED ALLERGEN DISC2Cleared 510(K)
- K880168INCSTAR'S BIRCH ALLERGEN DISC2Cleared 510(K)
- K874883WALNUT ALLERGEN DISC2Cleared 510(K)
- K874540MARSH ELDER ALLERGEN DISC2Cleared 510(K)
- K880567WHITE ASH ALLERGEN DISC2Cleared 510(K)
- K880415MESQUITE ALLERGEN DISC2Cleared 510(K)
- K880187INCSTAR'S DANDELION ALLERGEN DISC2Cleared 510(K)
- K880160DPC'S ALLERGEN-SPECIFIC IGE SYSTEM2Cleared 510(K)
- K875244ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM2Cleared 510(K)
- K875163GOLDENROD ALLERGEN DISC2Cleared 510(K)
- K875329IVT CENTRAL ALLERGY SCREEN2Cleared 510(K)
- K874717QUIDEL ALLERGY SCREEN2Cleared 510(K)
- K880547VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY2Cleared 510(K)
- K875328IVT WESTERN ALLERGY SCREEN2Cleared 510(K)
- K875168QUIDEL TOTAL IGE TEST2Cleared 510(K)
- K880003ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST2Cleared 510(K)
- K880001MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T32Cleared 510(K)
- K875125PROGENE(TM) IGE TEST2Cleared 510(K)
- K880002MULTI-ALLERGEN IGE FAST SCREEN (MOLDS)2Cleared 510(K)
- K875274TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))2Cleared 510(K)
- K874802FLIPSCREEN QAT2Cleared 510(K)
- K875066ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT2Cleared 510(K)
- K874169IVT NORTHEAST ALLERGY SCREEN2Cleared 510(K)
- K874168IVT SOUTHEAST ALLERGY SCREEN2Cleared 510(K)
- K874446MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)2Cleared 510(K)
- K874281MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT2Cleared 510(K)
- K874440LIVE OAK ALLERGEN DISC2Cleared 510(K)
- K874149FALSE RAGWEED ALLERGEN DISC2Cleared 510(K)
- K874150JOHNSON GRASS ALLERGEN DISC2Cleared 510(K)
- K873998TOTAL IGE FAST (TM) TEST PACKAGE2Cleared 510(K)
- K873969GIANT RAGWEED ALLERGEN DISC2Cleared 510(K)
- K873814IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST2Cleared 510(K)
- K873770BERMUDA GRASS ALLERGEN DISC2Cleared 510(K)
- K873112PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC2Cleared 510(K)
- K872946PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC2Cleared 510(K)
- K873648BAHIA ALLERGEN DISC2Cleared 510(K)
- K873193PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS2Cleared 510(K)
- K873676IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT2Cleared 510(K)
- K873486RED TOP ALLERGEN DISC2Cleared 510(K)
- K872280MODIFIED PHADEBAS RAST/PHADEZYM RAST2Cleared 510(K)
- K873406RRT SHORT RAGWEED TEST KIT2Cleared 510(K)
- K871684ALTERNARIA TENUIS ALLERGEN DISC2Cleared 510(K)
- K871723SWEET VERNAL ALLERGEN DISC2Cleared 510(K)
- K871599DELFIA(TM) HIGE KIT2Cleared 510(K)
- K871660WESTERN RAGWEED ALLERGEN DISC2Cleared 510(K)
- K870625IVT SOUTHWEST ALLERGY SCREEN2Cleared 510(K)
- K871331VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU.2Cleared 510(K)
- K870966TOTAL IGE MASTICK2Cleared 510(K)
- K870009VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.2Cleared 510(K)
- K870624VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY2Cleared 510(K)
- K864696ALLERG*ENS ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K870597D. FARINAE ALLERGEN DISC2Cleared 510(K)
- K870264CAT EPITHELIUM ALLERGEN DISC2Cleared 510(K)
- K870153ALLERGEN SPECIFIC IGG4 CONTROL SERA2Cleared 510(K)
- K864104ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST2Cleared 510(K)
- K870152ALLERGEN SPECIFIC CONTROLS2Cleared 510(K)
- K863967SPECIFIC IGE FAST(TM) TEST II2Cleared 510(K)
- K863743BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT2Cleared 510(K)
- K8637943M IGG4 FAST TEST PACKAGE2Cleared 510(K)
- K863394RAPID SPECIFIC IGE PROCEDURE2Cleared 510(K)
- K863973ELM ALLERGEN DISC2Cleared 510(K)
- K863844IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC2Cleared 510(K)
- K863036PHADEBAS RAST/PHADEZYM RAST ALLERTUBE2Cleared 510(K)
- K863123IMMUNO BIOTECH MUGWART ALLERGEN DISC2Cleared 510(K)
- K863355PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA2Cleared 510(K)
- K862901VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY2Cleared 510(K)
- K863098MEADOW FESCUE ALLERGEN DISC2Cleared 510(K)
- K862266MAPLE ALLERGEN DISC2Cleared 510(K)
- K862938JUNE GRASS ALLERGEN DISC2Cleared 510(K)
- K862939ORCHARD GRASS ALLERGEN DISC2Cleared 510(K)
- K862265COTTONWOOD ALLERGEN DISC2Cleared 510(K)
- K862176RUSSIAN THISTLE ALLERGEN DISC2Cleared 510(K)
- K862264ENGLISH PLAINTAIN ALLERGEN DISC2Cleared 510(K)
- K862173PERENNIAL RYE ALLERGEN DISC2Cleared 510(K)
- K862175WHITE OAK ALLERGEN DISC2Cleared 510(K)
- K854756SHORT RAGWEED ALLERGEN DISC2Cleared 510(K)
- K861184PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS2Cleared 510(K)
- K860027FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY2Cleared 510(K)
- K855053THABEST-IGE2Cleared 510(K)
- K854865PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX52Cleared 510(K)
- K854939PHADEBAS RAST/PHADEZYM RAST ALLERTUBES2Cleared 510(K)
- K853969PHADEBAS RAST TEST ALLERGEN DISCS2Cleared 510(K)
- K850895VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY2Cleared 510(K)
- K853456PHADEBAS RAST/PHADEZYM RAST ALLERTUBES2Cleared 510(K)
- K852794ALLERCOAT ALLERGEN DISCS2Cleared 510(K)
- K852189PHADEBAS RAST TEST ALLERGEN DISCS2Cleared 510(K)
- K852263PHADEBAS RAST/PHADEZYM RAST ALLERTUBES2Cleared 510(K)
- K851512ALLERGENETICS IGE FAST TEST2Cleared 510(K)
- K851273PHADEBAS RAST PHADEZYM RAST ALLERTUBES2Cleared 510(K)
- K844629MAST LUMINESCENT ALLERGY SYSTEM2Cleared 510(K)
- K843694MAST ALLERGY SYSTEM2Cleared 510(K)
- K845032PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS2Cleared 510(K)
- K843302NEW ALLERG. COATED MICROFILTER WELL STRI2Cleared 510(K)
- K842457PHADEXACT SERUM, ALLERGEN SPECIFIC IGE2Cleared 510(K)
- K841516VENTRESCREEN, MULTIPLE ALLERGEN DISCS2Cleared 510(K)
- K840670PHADEBAS RAST PHADEZYM MIX ALLERG2Cleared 510(K)
- K840876PHADEBAS RAST TEST -ALLERGEN DISCS2Cleared 510(K)
- K834526MAST INHALANT PROFILE2Cleared 510(K)
- K840537RAST ALLERGO SORBENT TEST2Cleared 510(K)
- K833418CHYMOFAST TEST2Cleared 510(K)
- K840360ALLERCOAT MULTISCREEN DISCS2Cleared 510(K)
- K834598LIGHT TEST2Cleared 510(K)
- K833885MAST INHALANT PROFILE2Cleared 510(K)
- K832344POLYSTYRENE MICROTITER PLATE IMMUNO-2Cleared 510(K)
- K832217VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD2Cleared 510(K)
- K831554NEIN ALLERGEN DISC IN VAST VENTREX TEST2Cleared 510(K)
- K831442PHADEBAS & PHADEZYM RAST ALLERGEN DISCS2Cleared 510(K)
- K831091NEW ALLERGEN DISC -VAST VENTEX ALLERGY2Cleared 510(K)
- K831045PHADEBAS & PHADEZYM RAST MIXED ALLERG2Cleared 510(K)
- K823592PHADEBAS & PHADEZYM RAST TEST ALLERG2Cleared 510(K)
- K830155PHADEBAS & PHADEZYM RAST ALLERGEN DISCS2Cleared 510(K)
- K823593INHALANT PROFILE-ALLERGEN-SPECIFIC IGE2Cleared 510(K)
- K830170RIASSIST RAST DATA REDUCTION/QUALITY2Cleared 510(K)
- K830096PHADEBAS & PHADEZYME RAST ALLERGEN DISC2Cleared 510(K)
- K823470ALLERCOAT ALLERGEN DISCS2Cleared 510(K)
- K822141PHADEBAS RAST TEST2Cleared 510(K)
- K821451VAST VENTREX ALLERGY SYSTEMS TESTS2Cleared 510(K)
- K820029KALLESTAD RAST REAGENTS2Cleared 510(K)
- K812414KALLESTAD 125I ANTISERUM TO HUMAN IGE2Cleared 510(K)
- K810462PHADEZYM RAST TEST2Cleared 510(K)
- K802556PHADEBAS RAST TEST2Cleared 510(K)
- K771578PHADEBAS RAST PENICLLOYL G/V TEST2Cleared 510(K)
- 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
ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K163370
- 510(k) Type
- Traditional
- Applicant
- Phadia AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/5/2017
- Days to Decision
- 155 days
- Submission Type
- Summary