21 C.F.R. § 862.1120

Blood gases (P CO2 , P O2 ) and blood pH test system.

Last amended: 2016Year: 2026Length: 63 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 862.1120 (2026)

(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.
21 C.F.R. § 862.1120: Blood gases (P CO2 , P O2 ) and blood pH test system. | Justis AI