21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
(a) Identification. A blood gases (P CO2 , P O2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (P CO2 , P O2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
(b) Classification. Class II.
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