21 C.F.R. § 862.1145 – Calcium test system. | Midpage
§ 862.1145
21 C.F.R. § 862.1145
Calcium test system.
(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).