Reagent, Russel Viper Venom

FDA product code GIR · Class I (low risk) · 21 CFR 864.8950 · Hematology

16510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K132130Reagent, Russel Viper Venom - la ScreenGIR · Special Dsrv, Inc.01/10/2014SE
K132076Reagent, Russel Viper Venom - la ConfirmGIR · Special Dsrv, Inc.01/10/2014SE
K110031Hemosil Drvvt Screen & Hemosil Drvvt ConfirmGIR · Traditional Instrumentation Laboratory CO08/24/2011SE
K083878Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon laGIR · Traditional R2 Diagnostics, Inc.06/25/2010SE
K061805Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmGIR · Traditional Diagnostica Stago, Inc.12/06/2006SE
K000528Accuclot Drvvt Confirm, Catalog No. A62119GIR · Traditional Sigma Diagnostics, Inc.04/07/2000SE
K000527Accuclot Drvvt Screen, Catalog No. A6094GIR · Traditional Sigma Diagnostics, Inc.04/07/2000SE
K990580Cryocheck la Sure, Model SUR25-10GIR · Traditional Precision Biologic07/28/1999SE
K990579Cryocheck la Check, Models CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)GIR · Traditional Precision Biologic07/23/1999SE
K990302Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to…GIR · Traditional Instrumentation Laboratory CO04/08/1999SE
K940490DV Test and DVV ConfirmGIR · Traditional American Diagnostica, Inc.04/05/1995SE
K932463Bioclot laGIR · Traditional Biopool AB09/27/1993SE
K922326Lupo-Test RegeantGIR · Traditional Graoipore , Ltd.04/06/1993SE
K922156Lucor Confirmatory ReagentGIR · Traditional Gradipore , Ltd.04/06/1993SE
K903037Lupo-Test ReagentGIR · Traditional Gradipore , Ltd.12/17/1990SE
K841365Dia ReptinGIR · Traditional Diatech, Inc.06/01/1984SE

Recalls

RecallProductFirmInitiated
Z-0779-2007 American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnosticStability of product not assured. An increase of clotting time for both normal and abnormal plasmas American Diagnostica, Inc.02/28/2007Terminated