21 CFR 862.1270
§ 862.1270 Estrogens (total, in pregnancy) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1270, § 862.1270 Estrogens (total, in pregnancy) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89094
- Permanent ID
ys:prov:89094@1- SHA-256
b0563e7c3a934e9b1f8095a3058651ce8581252d23fb3871605e8d6b8b360254
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Full text
(a) Identification. As estrogens (total, in pregnancy) test system is a device intended to measure total estrogens in plasma, serum, and urine during pregnancy. The device primarily measures estrone plus estradiol. Measurements of total estrogens are used to aid 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.