21 CFR 862.1175
§ 862.1175 Cholesterol (total) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1175, § 862.1175 Cholesterol (total) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89073
- Permanent ID
ys:prov:89073@1- SHA-256
442087c7e77d7c605cd312485782399f3189e2dcaa18d4f08bb5bb0ddbc72104
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Full text
(a) Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
(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.