21 CFR 862.1275
§ 862.1275 Estrogens (total, nonpregnancy) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1275, § 862.1275 Estrogens (total, nonpregnancy) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89095
- Permanent ID
ys:prov:89095@1- SHA-256
70ef89628ec0af7e3a18ff4befeced43493e2dce45b78225cf04d60fe027b0ac
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Full text
(a) Identification. As estrogens (total, nonpregnancy) test system is a device intended to measure the level of estrogens (total estrone, estradiol, and estriol) in plasma, serum, and urine of males and nonpregnant females. Measurement of estrogens (total, nonpregnancy) is used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea (absence of menses) differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.
(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.