NATIVE PROTHROMBIN ANTIGEN EIA
Device Facts
| Record ID | K910617 |
|---|---|
| Device Name | NATIVE PROTHROMBIN ANTIGEN EIA |
| Applicant | Organon Teknika Corp. |
| Product Code | DDF · Immunology |
| Decision Date | May 15, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5735 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.
