21 CFR § 862.1145 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1145 Calcium test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.1140 Calcitonin test system.§ 862.1150 Calibrator. →