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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.1145

§ 862.1145. Calcium test system.

49 words·~1 min read·/us/cfr/t21/s§ 862.1145·

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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.
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