21 CFR 862.1095
§ 862.1095 Ascorbic acid test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1095, § 862.1095 Ascorbic acid test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89054
- Permanent ID
ys:prov:89054@1- SHA-256
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Full text
(a) Identification. An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.
(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.