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GIR — Reagent, Russel Viper Venom Class I

FDA Device Classification

Classification Details

Product Code
GIR
Device Class
Class I
Regulation Number
864.8950
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K132130dsrvREAGENT, RUSSEL VIPER VENOM - LA SCREENJanuary 10, 2014
K132076dsrvREAGENT, RUSSEL VIPER VENOM - LA CONFIRMJanuary 10, 2014
K110031instrumentation laboratoryHEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRMAugust 24, 2011
K083878r2 diagnosticsLUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAJune 25, 2010
K061805diagnostica stagoSTA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRMDecember 6, 2006
K000528sigma diagnosticsACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119April 7, 2000
K000527sigma diagnosticsACCUCLOT DRVVT SCREEN, CATALOG NO. A6094April 7, 2000
K990580precision biologicCRYOCHECK LA SURE, MODEL SUR25-10July 28, 1999
K990579precision biologicCRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)July 23, 1999
K990302instrumentation laboratoryIL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDApril 8, 1999
K940490american diagnosticaDV TEST AND DVV CONFIRMApril 5, 1995
K932463biopoolBIOCLOT LASeptember 27, 1993
K922326graoiporeLUPO-TEST REGEANTApril 6, 1993
K922156gradiporeLUCOR CONFIRMATORY REAGENTApril 6, 1993
K903037gradiporeLUPO-TEST REAGENTDecember 17, 1990
K841365diatechDIA REPTINJune 1, 1984