ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
Device Facts
| Record ID | K000528 |
|---|---|
| Device Name | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | GIR · Hematology |
| Decision Date | Apr 7, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8950 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.
