21 C.F.R. § 864.5600 Automated hematocrit instrument.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices
§ 864.5600 Automated hematocrit instrument.