View all text of Subpart B [§ 862.1020 - § 862.1840]

§ 862.1085 - Angiotensin I and renin test system.

(a) 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.

(b) Classification. Class II.