21 C.F.R. § 864.8625 Hematology quality control mixture.
Title 21 - Food and Drugs
(a) Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC). (b) Classification. Class II (performance standards). [45 FR 60637, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart I—Hematology Reagents
§ 864.8625 Hematology quality control mixture.
