| Device Type ID | 2285 |
| Device Name | Reagent, Russel Viper Venom |
| Regulation Description | Russell Viper Venom Reagent. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.8950 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GIR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2285 |
| Device | Reagent, Russel Viper Venom |
| Product Code | GIR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Russell Viper Venom Reagent. |
| CFR Regulation Number | 864.8950 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DSRV, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3 |
| Total Device Problems | 3 |