JIE · Method, Ion-Exchange, Ammonia
Clinical Chemistry · 21 CFR 862.1065 · Class 1
Overview
| Product Code | JIE |
|---|---|
| Device Name | Method, Ion-Exchange, Ammonia |
| Regulation | 21 CFR 862.1065 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class I.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
