Regulatory Text
21 C.F.R. § 864.5300 — Red cell indices device.
§ 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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21 C.F.R. § 864.5300
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The regulatory text of 21 C.F.R. § 864.5300 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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