GIR · Class I · 21 CFR 864.8950

FDA Product Code GIR: Reagent, Russel Viper Venom

Leading manufacturers include Sigma Diagnostics, Inc., Instrumentation Laboratory CO and Precision Biologic.

16
Total
16
Cleared
201d
Avg days
1984
Since

FDA 510(k) Cleared Reagent, Russel Viper Venom Devices (Product Code GIR)

16 devices
1–16 of 16
Cleared Aug 24, 2011
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
K110031
Instrumentation Laboratory CO
Hematology · 231d
Cleared Dec 06, 2006
STA - STACLOT DRVV SCREEN
K061805
Diagnostica Stago, Inc.
Hematology · 162d
Cleared Apr 07, 2000
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
K000527
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Apr 07, 2000
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
K000528
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Jul 28, 1999
CRYOCHECK LA SURE, MODEL SUR25-10
K990580
Precision Biologic
Hematology · 155d
Cleared Jul 23, 1999
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
K990579
Precision Biologic
Hematology · 150d
Cleared Apr 08, 1999
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
K990302
Instrumentation Laboratory CO
Hematology · 66d
Cleared Jun 01, 1984
DIA REPTIN
K841365
Diatech, Inc.
Hematology · 60d

About Product Code GIR - Regulatory Context