21 CFR 864.7425 — Assay, Carboxyhemoglobin

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7425

Identification

A carboxyhemoglobin assay is a device used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning. This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, and gasometry.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
GHSAssay, Carboxyhemoglobin253rd Party
Innolitics

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