21 CFR § 862.1160 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1160 Bicarbonate/carbon dioxide test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

(b) Classification. Class II.

← § 862.1155 Human chorionic gonadotropin (HCG) test system.§ 862.1163 Cardiac allograft gene expression profiling test system. →