21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
(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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Federal Register documents that created or amended this section.