21 CFR 862.1360
§ 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1360, § 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89114
- Permanent ID
ys:prov:89114@1- SHA-256
4c120a5e0ae1a9dbe123b801bb3a738fc6494fb73514e9c040834cbf65d86888
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Full text
(a) Identification. A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
(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.