SYNTHASIL APTT REAGENT
Device Facts
| Record ID | K953981 |
|---|---|
| Device Name | SYNTHASIL APTT REAGENT |
| Applicant | Ortho Diagnostic Systems, Inc. |
| Product Code | GFO · Hematology |
| Decision Date | Nov 30, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7925 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
