21 CFR 862.1445
§ 862.1445 Lactate dehydrogenase isoenzymes test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1445, § 862.1445 Lactate dehydrogenase isoenzymes test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89132
- Permanent ID
ys:prov:89132@1- SHA-256
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Full text
(a) Identification. A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.
(b) Classification. Class II (special 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.