21 CFR 862.1120 — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1120

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph21883rd Party
SFOElectrode Measurement, Drain Effluent Ph21
Innolitics

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