862.1085 Angiotensin I and renin test system.§ 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.