21 CFR 862.1520
§ 862.1520 5′-Nucleotidase test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1520, § 862.1520 5′-Nucleotidase test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89150
- Permanent ID
ys:prov:89150@1- SHA-256
fdc46d378d9d80b350868dc6bc8d5d1d6aa44d1871ec6fae092282e34d575841
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Full text
(a) Identification. A 5′-nucleotidase test system is a device intended to measure the activity of the enzyme 5′-nucleotidase in serum and plasma. Measurements of 5′-nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver and bone diseases in the presence of elevated serum alkaline phosphatase activity.
(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.