HELENA PLASMINOGEN QUIPLATE PROCEDURE
Device Facts
| Record ID | K811777 |
|---|---|
| Device Name | HELENA PLASMINOGEN QUIPLATE PROCEDURE |
| Applicant | Helena Laboratories |
| Product Code | DDX · Immunology |
| Decision Date | Jul 2, 1981 |
| 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.
