864.5600 Automated hematocrit instrument.§ 864.5600 Automated hematocrit instrument.
(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]