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 CodeDevice NameClassDevicesAttributes
CIBRadioimmunoassay, Angiotensin I And Renin2163rd Party
Innolitics

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