CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES > SUBPART B—Clinical Chemistry Test Systems (§862.1020 to §862.1825) > 862.1120—Blood gases (P CO 2, P O 2) and blood pH test system.

862.1120—Blood gases (P CO 2, P O 2) and blood pH test system.

(a) Identification. A blood gases (PCO 2, PO 2) 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 (PCO 2, PO 2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
(b) Classification. Class II.