21 CFR 862.1815
§ 862.1815 Vitamin E test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1815, § 862.1815 Vitamin E test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89205
- Permanent ID
ys:prov:89205@1- SHA-256
1a7de89c74bfd7ae941b2ff9bf3d408af1541bc914f19fe92abc51e422e83d22
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A vitamin E test system is a device intended to measure vitamin E (tocopherol) in serum. Measurements obtained by this device are used in the diagnosis and treatment of infants with vitamin E deficiency syndrome.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 subject to the limitations in § 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.