Automated hematocrit instrument.

21 C.F.R. § 864.5600
in effectEffective: 2024-07-01
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(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).

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