ACS ONE-STAGE PROTHROMBIN TIME REAGENT
Device Facts
| Record ID | K902468 |
|---|---|
| Device Name | ACS ONE-STAGE PROTHROMBIN TIME REAGENT |
| Applicant | Analytical Control Systems, Inc. |
| Product Code | GJS · Hematology |
| Decision Date | Aug 10, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7750 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
