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
- K242170K-ASSAY CRP (Ver.2)2Cleared 510(K)
- K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge2Cleared 510(K)
- K192028Yumizen C1200 CRP2Cleared 510(K)
- K192118CRP Vario2Cleared 510(K)
- K191993Yumizen C1200 CRP2Cleared 510(K)
- K160712VITROS Chemistry Products hsCRP Reagent2Cleared 510(K)
- K142993QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument2Cleared 510(K)
- K152433VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 72Cleared 510(K)
- K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit2Cleared 510(K)
- K121558DIAZYME HSCRP POC TEST KIT2Cleared 510(K)
- K103557DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET2Cleared 510(K)
- K061138ABX PENTRA 400 : CRP2Cleared 510(K)
- K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-252Cleared 510(K)
- K052591NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT2Cleared 510(K)
- K050836CRP DIAGNOSTIC ASSAY2Cleared 510(K)
- K041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY2Cleared 510(K)
- K042442QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE2Cleared 510(K)
- K040241N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET2Cleared 510(K)
- K040579CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)2Cleared 510(K)
- K032663QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/22Cleared 510(K)
- K031607ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL2Cleared 510(K)
- K030044EXTENDED RANGE HS CRP KIT, CAT NO:92002Cleared 510(K)
- K024280WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET2Cleared 510(K)
- K030545CRP-LATEX (II)X2 SEIKEN ASSAY KIT2Cleared 510(K)
- K030626VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 72Cleared 510(K)
- K023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR2Cleared 510(K)
- K023269HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS2Cleared 510(K)
- K022176ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 682572Cleared 510(K)
- K022486K-ASSAY HS-CRP CONTROLS2Cleared 510(K)
- K021194RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM2Cleared 510(K)
- K021609RDI HS CRP KIT2Cleared 510(K)
- K013787NYCOCARD CRP2Cleared 510(K)
- K014084NYCOCARD CRP CONTROL2Cleared 510(K)
- K003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-11192Cleared 510(K)
- K010597SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT2Cleared 510(K)
- K011079K-ASSAY HS-CRP CONTROLS2Cleared 510(K)
- K010236IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT2Cleared 510(K)
- K002558K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE2Cleared 510(K)
- K002651C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET2Cleared 510(K)
- K001636C-REACTIVE PROTEIN ANTISERUM KIT2Cleared 510(K)
- K001009RANDOX C-REACTIVE PROTEIN2Cleared 510(K)
- K991385DADE BEHRING N HIGH SENSITIVITY CRP ASSAY2Cleared 510(K)
- K992312K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B2Cleared 510(K)
- K992311K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC2Cleared 510(K)
- K991224K-ASSAY CRP2Cleared 510(K)
- K991210K-ASSAY CRP CALIBRATOR SET2Cleared 510(K)
- K990704ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT2Cleared 510(K)
- K990886IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR52Cleared 510(K)
- K984132IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC52Cleared 510(K)
- K981871C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-421002Cleared 510(K)
- K982087ROCHE CRP T CONTROL N2Cleared 510(K)
- K981638IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT2Cleared 510(K)
- K973692UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE2Cleared 510(K)
- K974050SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT2Cleared 510(K)
- K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST2Cleared 510(K)
- K965110N-ASSAY TIA MULTI CRP CALIBRATOR SET2Cleared 510(K)
- K962049C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT2Cleared 510(K)
- K962019C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST2Cleared 510(K)
- K963061IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT2Cleared 510(K)
- K961829QUALITROL CRP CONTROL SET2Cleared 510(K)
- K962373N/T RHEUMATOLOGY CONTROL SL/1 AND SL/22Cleared 510(K)
- K962523N LATEX CRP MONO REAGENT2Cleared 510(K)
- K960702CRP-LATEX SEIKEN XR REAGENT SYSTEM2Cleared 510(K)
- K960324HEMAGEN CRP 150 KIT (EIA METHOD)2Cleared 510(K)
- K955156WAKO AUTOKIT CRP NEW2Cleared 510(K)
- K954447C-REACTIVE PROTEIN LATEX KIT2Cleared 510(K)
- K953926LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM2Cleared 510(K)
- K953207HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)2Cleared 510(K)
- K953197EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)2Cleared 510(K)
- K953212C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR2Cleared 510(K)
- K951057MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 22Cleared 510(K)
- K945280DUPONT DIMENSION C-REACTIVE PROTEIN METHOD2Cleared 510(K)
- K946050LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 22Cleared 510(K)
- K944375N/T RHEUMATOLOGY CONTROL SL/1, SL/22Cleared 510(K)
- K944288HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)2Cleared 510(K)
- K930621TINA-QUANT CRP2Cleared 510(K)
- K924332ACCUTEX CRP LATEX TEST2Cleared 510(K)
- K920845VIGIL II2Cleared 510(K)
- K923768PULSE CRP TEST2Cleared 510(K)
- K922722TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL2Cleared 510(K)
- K914155TIA CRP TEST KIT2Cleared 510(K)
- K905633HUMAN C-REACTIVE PROTEIN RID KIT2Cleared 510(K)
- K904312RHEUMAGEN CRP T-CONTROL2Cleared 510(K)
- K895598WAKO(TM) AUTOKIT CRP2Cleared 510(K)
- K894573SCANLISA HUMAN CRP ELISA KIT2Cleared 510(K)
- K892526SPQ TM TEST SYSTEM II FOR CRP2Cleared 510(K)
- K892198TECHNICON DPA-1 (TM) CRP METHOD2Cleared 510(K)
- K892146C REACTIVE PROTEIN LIQUID2Cleared 510(K)
- K892119QUIK-DOT C REACTIVE PROTEIN2Cleared 510(K)
- K890423V-TREND TARGET CRP TEST2Cleared 510(K)
- K884101DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR2Cleared 510(K)
- K882998ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST2Cleared 510(K)
- K880729KALLESTAD QM300 CALIBRATOR C PACK2Cleared 510(K)
- K880730KALLESTAD QM2/QM300 CONTROL C PACK2Cleared 510(K)
- K875345VISION(R) CRP2Cleared 510(K)
- K880016MODIFIED CRP LATEX TEST2Cleared 510(K)
- K873865CRP2Cleared 510(K)
- K871895TINA-QUANT [A] CRP2Cleared 510(K)
- K871055PRECIMAT(R) CRP2Cleared 510(K)
- K864131VISION(TM) CRP2Cleared 510(K)
- K863628C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS2Cleared 510(K)
- K863328ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST2Cleared 510(K)
- K863329ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR2Cleared 510(K)
- K860549DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR2Cleared 510(K)
- K860550DU PONT C-REACTIVE PROTEIN (CRP) ASSAY2Cleared 510(K)
- K854542TDX C-REACTIVE PROTEIN2Cleared 510(K)
- K854221DIESSE CRP TEST KIT2Cleared 510(K)
- K851842SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN2Cleared 510(K)
- K850160FISHER DIAGNOSTICS LATEST-CRP TEST KIT2Cleared 510(K)
- K850590SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN2Cleared 510(K)
- K841862IMMU-TEC2Cleared 510(K)
- K832054FIAX CRP TEST KIT2Cleared 510(K)
- K831958RADIAL IMMUNO-TEST FOR HUMAN C-REACTI2Cleared 510(K)
- K823415PRISMA C-REACTIVE PROTEIN CONTROLS2Cleared 510(K)
- K823416PRISMA C-REACTIVE PROTEIN ASSAY2Cleared 510(K)
- K823417PRISMA-C-REACTIVE PROTEIN CALIBRATORS2Cleared 510(K)
- K822067EMIT C-REACTIVE PROTEIN AUTOCAROUSEL2Cleared 510(K)
- K821984QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.2Cleared 510(K)
- K821412C-REACTIVE PROTEIN CONTROL2Cleared 510(K)
- K811617QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.2Cleared 510(K)
- K791461AGGLUTINOTEST-C-REACTIVE PROTEIN2Cleared 510(K)
- K792238CRPTELL2Cleared 510(K)
- K791560GOAT ANTI-HUMAN C-REACTIVE PROTEIN2Cleared 510(K)
- K791650HUMAN, C-REACTIVE PROTEIN (CRP)2Cleared 510(K)
- K760354TEST, SLIDE FOR C-REATIVE PROTEIN2Cleared 510(K)
- K760035TEST, C-REATIVE PROTEIN, LATEX SLIDE2Cleared 510(K)
- DCNSystem, Test, C-Reactive Protein2Product Code
- DCOAlpha-Globulin, Antigen, Antiserum, Control1Product Code
- DCTCeruloplasmin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DCYCeruloplasmin, Fitc, Antigen, Antiserum, Control2Product Code
- DDBCeruloplasmin, Antigen, Antiserum, Control2Product Code
- DDCThyroglobulin, Antigen, Antiserum, Control2Product Code
- DDDTransferrin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDGTransferrin, Antigen, Antiserum, Control2Product Code
- DDITransferrin, Fitc, Antigen, Antiserum, Control2Product Code
- DDJThyroglobulin, Fitc, Antigen, Antiserum, Control2Product Code
- DDKBeta-2-Glycoprotein Iii, Antigen, Antiserum, Control1Product Code
- DDLThyroglobulin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDNBeta-2-Glycoprotein I, Antigen, Antiserum, Control1Product Code
- DDOMyoglobin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDRMyoglobin, Antigen, Antiserum, Control2Product Code
- DDSPrealbumin, Fitc, Antigen, Antiserum, Control1Product Code
- DDTAlpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDYAlpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control2Product Code
- DDZAlbumin, Fitc, Antigen, Antiserum, Control2Product Code
- DEAMyoglobin, Fitc, Antigen, Antiserum, Control2Product Code
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control2Product Code
- DECInter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control1Product Code
- DEFAlpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEGLactoferrin, Antigen, Antiserum, Control1Product Code
- DEHLambda, Antigen, Antiserum, Control2Product Code
- DEIAlpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control2Product Code
- DEJAlpha-2-Glycoproteins, Antigen, Antiserum, Control1Product Code
- DEKKappa, Rhodamine, Antigen, Antiserum, Control2Product Code
- DELLipoprotein X, Antigen, Antiserum, Control1Product Code
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control2Product Code
- DENAlpha-1-T-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEOKappa, Fitc, Antigen, Antiserum, Control2Product Code
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control2Product Code
- DESLambda, Fitc, Antigen, Antiserum, Control2Product Code
- DETLactic Dehydrogenase, Antigen, Antiserum, Control1Product Code
- DEWIgg, Antigen, Antiserum, Control2Product Code
- DEXAlpha-1-B-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEZIgm, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFBAlpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control2Product Code
- DFFAlpha-1-Antichymotrypsin, Antigen, Antiserum, Control2Product Code
- DFGLambda, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFHKappa, Antigen, Antiserum, Control2Product Code
- DFITotal Spinal-Fluid, Antigen, Antiserum, Control1Product Code
- DFJAlbumin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFKIgg (Fab Fragment Specific), Antigen, Antiserum, Control1Product Code
- DFLIgm, Ferritin, Antigen, Antiserum, Control2Product Code
- DFMIge, Ferritin, Antigen, Antiserum, Control2Product Code
- DFOIgg, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFQSperm, Antigen, Antiserum, Control1Product Code
- DFSIgm, Fitc, Antigen, Antiserum, Control2Product Code
- DFTIgm, Antigen, Antiserum, Control2Product Code
- DFXSperm, Fitc, Antigen, Antiserum, Control1Product Code
- DFZIgg (Gamma Chain Specific), Antigen, Antiserum, Control2Product Code
- DGACohn Fraction Ii, Antigen, Antiserum, Control1Product Code
- DGCIge, Antigen, Antiserum, Control2Product Code
- DGDIgg, Ferritin, Antigen, Antiserum, Control2Product Code
- DGEIgd, Rhodamine, Antigen, Antiserum, Control2Product Code
- DGGIgd, Fitc, Antigen, Antiserum, Control2Product Code
- DGIBreast Milk, Rhodamine, Antigen, Antiserum, Control1Product Code
- DGJColostrum, Antigen, Antiserum, Control1Product Code
- DGKIgg, Fitc, Antigen, Antiserum, Control2Product Code
- DGLIge, Rhodamine, Antigen, Antiserum, Control2Product Code
- DGMBreast Milk, Antigen, Antiserum, Control1Product Code
- DGNBreast Milk, Fitc, Antigen, Antiserum, Control1Product Code
- DGPIge, Fitc, Antigen, Antiserum, Control2Product Code
- DGWSystem, Test, Hypersensitivity Pneumonitis2Product Code
- DGXNg1m(A), Antigen, Antiserum, Control1Product Code
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological2Product Code
- DHCSystem, Test, Systemic Lupus Erythematosus2Product Code
- DHINg3m(Bo), Antigen, Antiserum, Control1Product Code
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DHQNg3m(G), Antigen, Antiserum, Control1Product Code
- DHRSystem, Test, Rheumatoid Factor2Product Code
- DHYNg4m(A), Antigen, Antiserum, Control1Product Code
- JFQP-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin2Product Code
- JFRIndirect Copper Assay, Ceruloplasmin2Product Code
- JHRRadioimmunoassay, Immunoglobulins (D, E)2Product Code
- JKMImmunochemical, Bence-Jones Protein2Product Code
- JNLImmunochemical, Thyroglobulin Autoantibody2Product Code
- JNMImmunochemical, Transferrin2Product Code
- JZGSystem, Test, Beta-2-Microglobulin Immunological2Product Code
- JZHFactor B, Antigen, Antiserum, Control2Product Code
- JZJPrealbumin, Antigen, Antiserum, Control1Product Code
- JZOSystem, Test, Thyroid Autoantibody2Product Code
- KHTFraction V, Antigen, Antiserum, Control1Product Code
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase2Product Code
- KTMC3-Indirect Immunofluorescent Solid Phase2Product Code
- KTOReagent, Immunoassay, Igg1Product Code
- KTPComplement C3b Activator Immunoassay Reagents2Product Code
- KTSSecond Antibody (Species Specific Anti-Animal Gamma Globulin)2Product Code
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls2Product Code
- LKJAntinuclear Antibody, Antigen, Control2Product Code
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control1Product Code
- LKOAnti-Rnp Antibody, Antigen And Control2Product Code
- LKPAnti-Sm Antibody, Antigen And Control2Product Code
- LLLExtractable Antinuclear Antibody, Antigen And Control2Product Code
- 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
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K022176
- 510(k) Type
- Traditional
- Applicant
- Orion Diagnostica, Div. Orion Corp.
- Country
- Finland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/3/2002
- Days to Decision
- 153 days
- Submission Type
- Statement