Bicarbonate/carbon dioxide test system.

21 C.F.R. § 862.1160
in effectEffective: 2024-07-01
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(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.

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