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21 CFR 862.1145

§ 862.1145 Calcium test system.

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

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21 CFR 862.1145, § 862.1145 Calcium test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89065
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(a) Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). (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.