21 CFR 862.1605
§ 862.1605 Pregnanediol test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1605, § 862.1605 Pregnanediol test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89168
- Permanent ID
ys:prov:89168@1- SHA-256
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Full text
(a) Identification. A pregnanediol test system is a device intended to measure pregnanediol (a major urinary metabolic product of progesterone) in urine. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.