21 C.F.R. § 864.5600

Current through September 30, 2024
Section 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).

21 C.F.R. §864.5600

45 FR 60600, Sept. 12, 1980