§ 864.5600. Automated hematocrit instrument.
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/us/cfr/t21/s§ 864.5600·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
(b)Classification. Class II (performance standards). [45 FR 60600, Sept. 12, 1980]