21 C.F.R. § 864.5300   Red cell indices device.

Title 21 - Food and Drugs


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

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§ 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).

[45 FR 60597, Sept. 12, 1980]

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