Regulation Text
(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.
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.