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21 C.F.R. § 862.1120   Blood gases (P_CO2, P_O2) and blood pH test system.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems

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§ 862.1120   Blood gases (P_CO2, P_O2) and blood pH test system.

(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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