COATEST PLASMINOGEN
Device Facts
| Record ID | K854572 |
|---|---|
| Device Name | COATEST PLASMINOGEN |
| Applicant | Kabivitrum, Inc. |
| Product Code | DDX · Immunology |
| Decision Date | Feb 26, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5715 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the plasminogen (an inactive substance from which plasmin, a blood-clotting factor, is formed) in serum, other body fluids, and tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.
