Code of Federal Regulations · Section

§ 862.1145 — Calcium Test System

21 C.F.R. § 862.1145

View:

(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. § 862.1140 21 C.F.R. § 862.1150

Authorizing Statute