RIA-QUANT FPA TEST KIT
Device Facts
| Record ID | K821151 |
|---|---|
| Device Name | RIA-QUANT FPA TEST KIT |
| Applicant | Mallinckrodt Critical Care |
| Product Code | DAN · Immunology |
| Decision Date | Jul 22, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5350 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A fibrinopeptide A immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the fibrinopeptide A (a blood-clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may aid in the diagnosis and treatment of certain blood-clotting disorders.
