21 CFR 862.1120 - Blood gases (PCO2, PO2) and blood pH test system.

Regulations last checked for updates: May 07, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart B [§ 862.1020 - § 862.1840]

§ 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.

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371

source: 52 FR 16122, May 1, 1987, unless otherwise noted.

cite as: 21 CFR 862.1120