Product code GIR
- Device name
- Reagent, Russel Viper Venom
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.8950
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132076 | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM | Dsrv, Inc. | 2014-01-10 |
| K132130 | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | Dsrv, Inc. | 2014-01-10 |
| K110031 | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM | Instrumentation Laboratory CO | 2011-08-24 |
| K083878 | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | R2 Diagnostics, Inc. | 2010-06-25 |
| K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | Diagnostica Stago, Inc. | 2006-12-06 |
| K000527 | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | Sigma Diagnostics, Inc. | 2000-04-07 |
| K000528 | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | Sigma Diagnostics, Inc. | 2000-04-07 |
| K990580 | CRYOCHECK LA SURE, MODEL SUR25-10 | Precision Biologic | 1999-07-28 |
| K990579 | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) | Precision Biologic | 1999-07-23 |
| K990302 | IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) | Instrumentation Laboratory CO | 1999-04-08 |
| K940490 | DV TEST AND DVV CONFIRM | American Diagnostica, Inc. | 1995-04-05 |
| K932463 | BIOCLOT LA | Biopool AB | 1993-09-27 |
| K922156 | LUCOR CONFIRMATORY REAGENT | Gradipore , Ltd. | 1993-04-06 |
| K922326 | LUPO-TEST REGEANT | Graoipore , Ltd. | 1993-04-06 |
| K903037 | LUPO-TEST REAGENT | Gradipore , Ltd. | 1990-12-17 |
| K841365 | DIA REPTIN | Diatech, Inc. | 1984-06-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414639451 | LA 2 Confirmation Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-29 |
| 00630414639765 | LA 1 Screening Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-29 |
| 00842768019661 | LA 2 Confirmation Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-29 |
| 00842768019654 | LA 1 Screening Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-29 |
| 00842768007491 | LA 2 Confirmation Reagent | Siemens Healthcare Diagnostics Products GmbH | 2020-09-24 |
| 00842768007477 | LA 1 Screening Reagent | Siemens Healthcare Diagnostics Products GmbH | 2020-09-24 |
| 15391521420487 | TriniCLOT Lupus Confirm | TCOAG IRELAND LIMITED | 2019-06-28 |
| 15391521420470 | TriniCLOT Lupus Screen | TCOAG IRELAND LIMITED | 2019-06-28 |
| 10859394006115 | LupoTek Correctin VL | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006139 | PlasmaCon LA | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006122 | PlasmaCon LA | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006108 | LupoTek Detectin VL | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 08426950513704 | HemosIL dRVVT Screen | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 00843876000480 | CRYOcheck™ LA Sure™ | Precision Biologic Inc | 2016-09-23 |
| 00843876000473 | CRYOcheck™ LA Check™ | Precision Biologic Inc | 2016-09-23 |
| 00843876000466 | CRYOcheck™ LA Check™ | Precision Biologic Inc | 2016-09-23 |
| 00843876000459 | CRYOcheck™ LA Check™ | Precision Biologic Inc | 2016-09-23 |
| 00843876000442 | CRYOcheck™ LA Check™ | Precision Biologic Inc | 2016-09-23 |
| 08426950513711 | HemosIL dRVVT Confirm | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 00850201006017 | DVVtest 10 | Biomedica ADI Inc. | 2016-09-20 |
| 00850201006024 | DVVconfirm 5 | Biomedica ADI Inc. | 2016-09-20 |
| 00850201006062 | DVVtest 25 | Biomedica ADI Inc. | 2016-09-20 |
| 00850201006123 | DVVconfirm 10 | Biomedica ADI Inc. | 2016-09-20 |
| 13607450003397 | STA® - Staclot® dRVV Screen 2 | DIAGNOSTICA STAGO | 2016-09-15 |
| 13607450003342 | STA® - Staclot® dRVV Confirm | DIAGNOSTICA STAGO | 2016-09-15 |
| 13607450003335 | STA® - Staclot® dRVV Screen 5 | DIAGNOSTICA STAGO | 2016-09-15 |