21 CFR 862.1670
§ 862.1670 Sorbitol dehydrogenase test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1670, § 862.1670 Sorbitol dehydrogenase test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89182
- Permanent ID
ys:prov:89182@1- SHA-256
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Full text
(a) Identification. A sorbitol dehydrogenase test system is a device intended to measure the activity of the enzyme sorbitol dehydrogenase in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders such as cirrhosis or acute hepatitis.
(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 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.