§ 864.5620. Automated hemoglobin system.
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/us/cfr/t21/s§ 864.5620·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]