Reagent, Russel Viper Venom
Hematology · 21 CFR 864.8950
Recent MDR events
4 adverse event reports on file
- LA 1 SCREENING REAGENTMar 14, 2018MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2018-00034
- LA 1 SCREENING REAGENTMar 14, 2018MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2018-00033
- LA 1 SCREENING REAGENTMar 14, 2018MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2018-00032
- LA1 SCREENING REAGENT/LA2 CONFIRMATION REAGENTJul 26, 2005MalfunctionDade Behring Gmbh9610806-2005-00015
Event type breakdown
Most-reported manufacturers
Registered firms
21 firms currently registered for this product code
Diagnostica Stago, Inc.
PARSIPPANY, NJ, US
Diagnostica Stago - Taverny
Taverny Val-d'Oise, FR
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
Precision Biologic Inc.
Dartmouth Nova Scotia, CA
Dsrv, Inc.
Mount Olive, NJ, US
Biomedica Diagnostics Inc.
Windsor Nova Scotia, CA
Bit Analytical Solutions Gmbh
SCHWALBACH/TAUNUS Hesse, DE
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Tcoag Ireland Limited
BRAY Wicklow, IE
R2 Diagnostics, Inc.
SOUTH BEND, IN, US
Instrumentation Laboratory Co. - Devens
Devens, MA, US
510(k) clearances
16 clearances for this product code
- Dsrv, Inc.Jan 10, 2014
K132076 · REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
- Dsrv, Inc.Jan 10, 2014
K132130 · REAGENT, RUSSEL VIPER VENOM - LA SCREEN
- Instrumentation Laboratory COAug 24, 2011
K110031 · HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
- R2 Diagnostics, Inc.Jun 25, 2010
K083878 · LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
- Diagnostica Stago, Inc.Dec 6, 2006
K061805 · STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
- Sigma Diagnostics, Inc.Apr 7, 2000
K000528 · ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
- Sigma Diagnostics, Inc.Apr 7, 2000
K000527 · ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
- Precision BiologicJul 28, 1999
K990580 · CRYOCHECK LA SURE, MODEL SUR25-10