21 C.F.R. § 862.1250

Current through September 30, 2024
Section 862.1250 - Desoxycorticosterone test system
(a)Identification. A desoxycorticosterone test system is a device intended to measure desoxycorticosterone (DOC) in plasma and urine. DOC measurements are used in the diagnosis and treatment of patients with hypermineralocorticoidism (excess retention of sodium and loss of potassium) and other disorders of the adrenal gland.
(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. §862.1250

52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000