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e-CFR data is current as of November 25, 2020

Title 21Chapter ISubchapter HPart 864Subpart F → §864.5600


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices


§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]

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