21 C.F.R. § 862.1145

Current through October 31, 2024
Section 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).
(b)Classification. Class II.

21 C.F.R. § 862.1145