21 C.F.R. § 864.5300

Current through May 31, 2024
Section 864.5300 - Red cell indices device
(a)Identification. A red cell indices device, usually part of a larger system, calculates or directly measures the erythrocyte mean corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the mean corpuscular hemoglobin concentration (MCHC). The red cell indices are used for the differential diagnosis of anemias.
(b)Classification. Class II (performance standards).

21 C.F.R. §864.5300

45 FR 60597, Sept. 12, 1980