21 C.F.R. § 862.1145

Calcium test system.

Last amended: 2016Year: 2026Length: 49 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 862.1145 (2026)

(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.
21 C.F.R. § 862.1145: Calcium test system. | Justis AI