21 CFR 864.5600 - Automated hematocrit instrument.
|Updated to:||April 2013|
Title 21: Food and DrugsCHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) SUBCHAPTER H: MEDICAL DEVICES 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]