21 CFR 862.1440
§ 862.1440 Lactate dehydrogenase test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1440, § 862.1440 Lactate dehydrogenase test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89131
- Permanent ID
ys:prov:89131@1- SHA-256
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Full text
(a) Identification. A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
(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 § 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.