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§ 862.1120 Blood gases (P<sub>CO2</sub>, P<sub>O2</sub>) and blood pH test system.

21 CFR 862.1120

  1. CFR
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  3. Title 21
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  5. Chapter I
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  7. Part 862
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  9. Subpart B
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  11. 21 CFR 862.1120
Citation21 CFR 862.1120
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 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.