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21 CFR 862.1160

§ 862.1160 Bicarbonate/carbon dioxide test system.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 862.1160, § 862.1160 Bicarbonate/carbon dioxide test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89068
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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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.