Hematology

DAP · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Hematology · 21 CFR 864.7320 · Class 2

Overview

Product CodeDAP
Device NameFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Regulation21 CFR 864.7320
Device ClassClass 2
Review PanelHematology
3rd-Party ReviewableYes

Cleared Devices (57)

RecordDevice NameApplicantDecision DateDecision
K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CONov 22, 2017SESE
K162227STA® - Liatest® D-DiDiagnostica StagoDec 10, 2016SESE
K160885HemosIL D-Dimer HSInstrumentation Laboratory COOct 27, 2016SESE
K151534HemosIL D-Dimer HSInstrumentation Laboratory COJul 6, 2015SESE
K141144STA LIATEST D-DIDiagnostica StagoSep 3, 2014SESE
K112818VIDAS D-DIMER EXCLUSION II (DEX2)bioMerieux, Inc.Jul 31, 2012SESE
K110303STRATUS CS ACUTE CARE D-DIMERSiemens Healthcare DiagnosticsMay 16, 2011SESE
K093626INNOVANCE D-DIMER, MODEL OPBP09Siemens Healthcare DiagnosticsNov 29, 2010SESE
K090264HEMOSIL D-DIMER HS 500, CONTROLSInstrumentation Laboratory COFeb 5, 2010SESE
K091916INNOVANCE D-DIMER, MODEL OPBP09Siemens Healthcare DiagnosticsOct 29, 2009SESE
K081732INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLSSiemens Healthcare DiagnosticsOct 24, 2008SESE
K073042HEMOSIL D-DIMERInstrumentation LaboratoryJul 31, 2008SESE
K080069DIMERTESTAmerican Diagnostica, Inc.Feb 13, 2008SESE
K070927HEMOSIL D-DIMER HSInstrumentation Laboratory COSep 17, 2007SESE
K063356STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAKDade Behring, Inc.Mar 23, 2007SESE
K051597STRATUS CS D-DIMERDade Behring, Inc.Aug 17, 2005SESE
K050544HEMOSIL D-DIMER HSInstrumentation Laboratory COApr 26, 2005SESE
K050278HEMOSIL D-DIMERInstrumentation Laboratory COMar 10, 2005SESE
K042723TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300Biosite IncorporatedDec 7, 2004SESE
K033491ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLSRoche Diagnostics Corp.Sep 1, 2004SESE
K041438ADVANCED D-DIMER ASSAYDade Behring, Inc.Aug 11, 2004SESE
K040437TRIAGE PROFILER S.O.B. PANELBiosite IncorporatedJun 25, 2004SESE
K040882VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442bioMerieux, Inc.Jun 10, 2004SESE
K032419QUANTEX D-DIMERInstrumentation Laboratory COOct 24, 2003SESE
K030328VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442bioMerieux, Inc.Sep 2, 2003SESE
K030687K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091CKamiya Biomedical Co.Jun 27, 2003SESE
K022976STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-DDade Behring, Inc.Jan 16, 2003SESE
K022977STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-CDade Behring, Inc.Nov 27, 2002SESE
K020810VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442bioMerieux, Inc.Oct 3, 2002SESE
K012755AUTODIMER ASSAY MODEL # 1431Xtrana, Inc.Mar 15, 2002SESE
K013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971Sigma Diagnostics, Inc.Dec 26, 2001SESE
K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221Sigma Diagnostics, Inc.Nov 15, 2001SESE
K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096Sigma Diagnostics, Inc.Nov 15, 2001SESE
K002948K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENTKamiya Biomedical Co.May 18, 2001SESE
K002706ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHIRoche Diagnostics Corp.Mar 16, 2001SESE
K003267SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-ASigma Diagnostics, Inc.Mar 15, 2001SESE
K002642MINIQUANT D-DIMER, MODEL 1447Biopool Intl., Inc.Feb 5, 2001SESE
K000492MDA D-DIMEROrganon Teknika Corp.Jun 7, 2000SESE
K992957ADVANCED D-DIMERDade Behring, Inc.Jan 28, 2000SESE
K974596DIMERTEST LATEX ASSAYAgen Biomedical , Ltd.May 26, 1998SESE
K974776MDA D-DIMEROrganon Teknika Corp.Apr 16, 1998SESE
K973819VIDAS D-DIMER (DD) ASSAYBiomerieux Vitek, Inc.Mar 10, 1998SESE
K972696IL TEST D-DIMERInstrumentation Laboratory CONov 4, 1997SESE
K964728STA-LIATEST D-DI TEST KITAmerican Bioproducts Co.Jun 26, 1997SESE
K964718STA D-DI CALIBRATOR KITAmerican Bioproducts Co.May 23, 1997SESE
K943571MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTSMore DiagnosticsJun 15, 1995SESE
K943787AURATEK FDPOrganon Teknika Corp.Sep 20, 1994SESE
K932657FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2More DiagnosticsNov 2, 1993SESE
K915698FIBRINOSTIKA TDP MICROELISA SYSTEMOrganon Teknika Corp.Aug 5, 1992SESE
K920943FDP PLASMA TEST KITAmerican Bioproducts Co.Jul 13, 1992SESE
K915203D-DIMER WELLCOTEST (HA10)Wellcome DiagnosticsJan 31, 1992SESE
K915503FIBRINOGEN FDP CONTROLCala DiagnosticsJan 30, 1992SESE
K912876FIBRINOSTIKA FBDP MICROELISA SYSTEMOrganon Teknika Corp.Oct 9, 1991SESE
K890189AGEN DIMERTEST EIAAgen Biomedical , Ltd.Mar 3, 1989SESE
K882944DIMERTEST(R) LATEXAgen Biomedical , Ltd.Aug 17, 1988SESE
K872195DATA-FI DIMERTEST LATEX ASSAYAmerican DadeAug 6, 1987SESE
K862156ASSERACHROM D-DI KITAmerican Bioproducts Co.Sep 16, 1986SESE

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