GIR · Reagent, Russel Viper Venom
Hematology · 21 CFR 864.8950 · Class 1
Overview
| Product Code | GIR |
|---|---|
| Device Name | Reagent, Russel Viper Venom |
| Regulation | 21 CFR 864.8950 |
| Device Class | Class 1 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132130 | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | Dsrv, Inc. | Jan 10, 2014 | SESE |
| K132076 | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM | Dsrv, Inc. | Jan 10, 2014 | SESE |
| K110031 | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM | Instrumentation Laboratory CO | Aug 24, 2011 | SESE |
| K083878 | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | R2 Diagnostics, Inc. | Jun 25, 2010 | SESE |
| K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | Diagnostica Stago, Inc. | Dec 6, 2006 | SESE |
| K000528 | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | Sigma Diagnostics, Inc. | Apr 7, 2000 | SESE |
| K000527 | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | Sigma Diagnostics, Inc. | Apr 7, 2000 | SESE |
| K990580 | CRYOCHECK LA SURE, MODEL SUR25-10 | Precision Biologic | Jul 28, 1999 | SESE |
| K990579 | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) | Precision Biologic | Jul 23, 1999 | SESE |
| K990302 | IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) | Instrumentation Laboratory CO | Apr 8, 1999 | SESE |
| K940490 | DV TEST AND DVV CONFIRM | American Diagnostica, Inc. | Apr 5, 1995 | SESE |
| K932463 | BIOCLOT LA | Biopool AB | Sep 27, 1993 | SESE |
| K922326 | LUPO-TEST REGEANT | Graoipore , Ltd. | Apr 6, 1993 | SESE |
| K922156 | LUCOR CONFIRMATORY REAGENT | Gradipore , Ltd. | Apr 6, 1993 | SESE |
| K903037 | LUPO-TEST REAGENT | Gradipore , Ltd. | Dec 17, 1990 | SESE |
| K841365 | DIA REPTIN | Diatech, Inc. | Jun 1, 1984 | SESE |
Top Applicants
- Dsrv, Inc. — 2 clearances
- Gradipore , Ltd. — 2 clearances
- Instrumentation Laboratory CO — 2 clearances
- Precision Biologic — 2 clearances
- Sigma Diagnostics, Inc. — 2 clearances
