§ 862.1395. 17-Hydroxyprogesterone test system.
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/us/cfr/t21/s§ 862.1395·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.
(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. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]