21 CFR 864.7490 — Assay, Sulfhemoglobin

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7490

Identification

A sulfhemoglobin assay is a device consisting of the reagents, calibrators, controls, and instrumentation used to determine the sulfhemoglobin (a compound of sulfur and hemoglobin) content of human blood as an aid in the diagnosis of sulfhemoglobinemia (presence of sulfhemoglobin in the blood due to drug administration or exposure to a poison). This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, or gasometry.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
GJCAssay, Sulfhemoglobin203rd Party
Innolitics

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