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21 CFR 862.1050

§ 862.1050 Alkaline phosphatase or isoenzymes test system.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 862.1050, § 862.1050 Alkaline phosphatase or isoenzymes test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89043
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(a) Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. (b) Classification. Class II.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.