21 C.F.R. § 862.1195

Current through October 31, 2024
Section 862.1195 - Corticoids test system
(a)Identification. A corticoids test system is a device intended to measure the levels of corticoids (hormones of the adrenal cortex) in serum and p lasma. Measurements of corticoids are used in the diagnosis and treatment of disorders of the cortex of the adrenal glands, especially those associated with hypertension and electrolyte disturbances.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9 .

21 C.F.R. §862.1195

52 FR 16122, May 1, 1987, as amended at 65 FR 2305 , Jan. 14, 2000