Title 21

SECTION 864.5620

864.5620 Automated hemoglobin system.

§ 864.5620 Automated hemoglobin system.

(a) 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.

(b) Classification. Class II (performance standards).

[45 FR 60601, Sept. 12, 1980]

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