Electronic Code of Federal Regulations
|
e-CFR data is current as of March 4, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1610 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§862.1610 Pregnanetriol test system.
(a) Identification. A pregnanetriol test system is a device intended to measure pregnanetriol (a precursor in the biosynthesis of the adrenal hormone cortisol) in urine. Measurements obtained by this device are used in the diagnosis and treatment of congenital adrenal hyperplasia (congenital enlargement 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.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]