21 CFR 862.1065 — Photometric Method, Ammonia
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1065
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JID | Photometric Method, Ammonia | 1 | 3 | 3rd Party |
| JIE | Method, Ion-Exchange, Ammonia | 1 | 0 | 3rd Party |
| JIF | Enzymatic Method, Ammonia | 1 | 30 | 3rd Party |
| JIG | Electrode, Ion-Specific Method, Ammonia | 1 | 0 | 3rd Party |
