21 CFR 864.5620 — System, Hemoglobin, Automated

Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5620

Identification

An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
GKRSystem, Hemoglobin, Automated239
Innolitics

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