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e-CFR data is current as of October 20, 2020

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1120


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


§862.1120   Blood gases (PCO2, PO2) and blood pH test system.

(a) Identification. A blood gases (PCO2, PO2) 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 (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

(b) Classification. Class II.

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