21 CFR 862.1265
§ 862.1265 Estriol test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1265, § 862.1265 Estriol test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89093
- Permanent ID
ys:prov:89093@1- SHA-256
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Full text
(a) Identification. An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.
(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.