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]