21 C.F.R. § 862.1160

Current through November 30, 2024
Section 862.1160 - Bicarbonate/carbon dioxide test system
(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.

21 C.F.R. § 862.1160