AGGLUTEX MORPHINE TEST KIT
Device Facts
| Record ID | K812985 |
|---|---|
| Device Name | AGGLUTEX MORPHINE TEST KIT |
| Applicant | Hoffmann-La Roche, Inc. |
| Product Code | DDF · Immunology |
| Decision Date | Dec 31, 1981 |
| 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.
