21 C.F.R. § 862.1370

Current through September 30, 2024
Section 862.1370 - Human growth hormone test system
(a)Identification. A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary 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. §862.1370

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