Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart I — Hematology Reagents](/submissions/HE/subpart-i%E2%80%94hematology-reagents) → [21 CFR 864.8950](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8950) → GIR — Reagent, Russel Viper Venom

# GIR · Reagent, Russel Viper Venom

_Hematology · 21 CFR 864.8950 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR

## Overview

- **Product Code:** GIR
- **Device Name:** Reagent, Russel Viper Venom
- **Regulation:** [21 CFR 864.8950](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8950)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)
- **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](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K132130.md) | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | Dsrv, Inc. | Jan 10, 2014 | SESE |
| [K132076](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K132076.md) | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM | Dsrv, Inc. | Jan 10, 2014 | SESE |
| [K110031](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K110031.md) | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM | Instrumentation Laboratory CO | Aug 24, 2011 | SESE |
| [K083878](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K083878.md) | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | R2 Diagnostics, Inc. | Jun 25, 2010 | SESE |
| [K061805](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K061805.md) | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | Diagnostica Stago, Inc. | Dec 6, 2006 | SESE |
| [K000528](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K000528.md) | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | Sigma Diagnostics, Inc. | Apr 7, 2000 | SESE |
| [K000527](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K000527.md) | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | Sigma Diagnostics, Inc. | Apr 7, 2000 | SESE |
| [K990580](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K990580.md) | CRYOCHECK LA SURE, MODEL SUR25-10 | Precision Biologic | Jul 28, 1999 | SESE |
| [K990579](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K990579.md) | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) | Precision Biologic | Jul 23, 1999 | SESE |
| [K990302](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K990302.md) | 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](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K940490.md) | DV TEST AND DVV CONFIRM | American Diagnostica, Inc. | Apr 5, 1995 | SESE |
| [K932463](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K932463.md) | BIOCLOT LA | Biopool AB | Sep 27, 1993 | SESE |
| [K922326](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K922326.md) | LUPO-TEST REGEANT | Graoipore , Ltd. | Apr 6, 1993 | SESE |
| [K922156](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K922156.md) | LUCOR CONFIRMATORY REAGENT | Gradipore , Ltd. | Apr 6, 1993 | SESE |
| [K903037](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K903037.md) | LUPO-TEST REAGENT | Gradipore , Ltd. | Dec 17, 1990 | SESE |
| [K841365](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K841365.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR)

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