Reagent, Russel Viper Venom
Reagent, Russell Viper Venom (product code GIR) is a hematology reagent derived from Russell's viper venom that activates Factor X directly, used in coagulation tests such as the dilute Russell viper venom time (dRVVT) to detect lupus anticoagulants and investigate coagulation pathway abnormalities. This device is classified as FDA Class 1, the lowest risk category, and requires 510(k) premarket notification. Regulated under 21 CFR 864.8950 in the Hematology specialty (HE), it is eligible for third-party review.
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Basic Information
- Product Code
- GIR
- Device Class
- FDA class 1
- Regulation Number
- 864.8950
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K132130 | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | Jan 10, 2014 | Substantially Equivalent | Dsrv, Inc. |
| K132076 | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM | Jan 10, 2014 | Substantially Equivalent | Dsrv, Inc. |
| K110031 | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM | Aug 24, 2011 | Substantially Equivalent | Instrumentation Laboratory CO |
| K083878 | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | Jun 25, 2010 | Substantially Equivalent | R2 Diagnostics, Inc. |
| K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | Dec 06, 2006 | Substantially Equivalent | Diagnostica Stago, Inc. |
| K000528 | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | Apr 07, 2000 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K000527 | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | Apr 07, 2000 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K990580 | CRYOCHECK LA SURE, MODEL SUR25-10 | Jul 28, 1999 | Substantially Equivalent | Precision Biologic |
| K990579 | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) | Jul 23, 1999 | Substantially Equivalent | Precision Biologic |
| K990302 | IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) | Apr 08, 1999 | Substantially Equivalent | Instrumentation Laboratory CO |
| K940490 | DV TEST AND DVV CONFIRM | Apr 05, 1995 | Substantially Equivalent | American Diagnostica, Inc. |
| K932463 | BIOCLOT LA | Sep 27, 1993 | Substantially Equivalent | Biopool AB |
| K922326 | LUPO-TEST REGEANT | Apr 06, 1993 | Substantially Equivalent | Graoipore , Ltd. |
| K922156 | LUCOR CONFIRMATORY REAGENT | Apr 06, 1993 | Substantially Equivalent | Gradipore , Ltd. |
| K903037 | LUPO-TEST REAGENT | Dec 17, 1990 | Substantially Equivalent | Gradipore , Ltd. |
| K841365 | DIA REPTIN | Jun 01, 1984 | Substantially Equivalent | Diatech, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.