View all text of Subpart B [§ 862.1020 - § 862.1840]
§ 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.