VENOM TIEM REAGENT
Device Facts
| Record ID | K955115 |
|---|---|
| Device Name | VENOM TIEM REAGENT |
| Applicant | Medical Diagnostic Technologies, Inc. |
| Product Code | JCO · Hematology |
| Decision Date | Apr 3, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen levels to aid in the evaluation of disseminated intravascular coagulation (nonlocalized clotting in the blood vessels) in patients receiving heparin therapy (the administration of the anticoagulant heparin in the treatment of thrombosis) or as an aid in the classification of dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen).
