21 CFR 862.1085 — Radioimmunoassay, Angiotensin I And Renin
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1085
Identification
An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CIB | Radioimmunoassay, Angiotensin I And Renin | 2 | 16 | 3rd Party |