FDA product code GIR: Reagent, Russel Viper Venom
GIR is the FDA product code for reagent, russel viper venom. It is a Class I device, regulated under 21 CFR 864.8950 and reviewed by the Hematology panel. FDA has cleared 16 510(k) submissions under GIR, from 11 different applicants. The average 510(k) review took 201 days (median 160). FDA has posted 1 recall for GIR devices.
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Russel Viper Venom |
| Device class | Class I |
| Regulation | 21 CFR 864.8950 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GIR clearance
Top GIR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dsrv, Inc. | 2 | 2014-01-10 |
| Instrumentation Laboratory CO | 2 | 2011-08-24 |
| Sigma Diagnostics, Inc. | 2 | 2000-04-07 |
| Precision Biologic | 2 | 1999-07-28 |
| Gradipore , Ltd. | 2 | 1993-04-06 |
6 more applicants have GIR clearances. See the full list in Caduvo.
Most recent GIR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132076 | Dsrv, Inc. | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM | 2014-01-10 | 191 |
| K132130 | Dsrv, Inc. | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | 2014-01-10 | 184 |
| K110031 | Instrumentation Laboratory CO | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM | 2011-08-24 | 231 |
| K083878 | R2 Diagnostics, Inc. | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | 2010-06-25 | 543 |
| K061805 | Diagnostica Stago, Inc. | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | 2006-12-06 | 162 |
Recalls for GIR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-02-28.
Frequently asked questions
What is FDA product code GIR?
GIR is the FDA product code for reagent, russel viper venom. It is a Class I device, regulated under 21 CFR 864.8950 and reviewed by the Hematology panel.
What device class is GIR?
Class I, regulation 21 CFR 864.8950. Typical premarket route: 510(k).
How long does a 510(k) take for product code GIR?
Across 16 cleared submissions the average was 201 days from receipt to decision (median 160).
Which companies have the most GIR clearances?
Dsrv, Inc. (2); Instrumentation Laboratory CO (2); Sigma Diagnostics, Inc. (2); Precision Biologic (2); Gradipore , Ltd. (2).
Have GIR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-02-28.
Next steps
- Run an FDA pathway report with predicate devices for product code GIR
- Run a recall and safety report across every GIR manufacturer
- Watch product code GIR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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