ROCHE REAGENT FOR AMMONIA
Device Facts
| Record ID | K913124 |
|---|---|
| Device Name | ROCHE REAGENT FOR AMMONIA |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | JIF · Clinical Chemistry |
| Decision Date | Aug 12, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1065 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
