21 C.F.R. § 864.9650 Quality control kit for blood banking reagents.
Title 21 - Food and Drugs
(a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking. (b) Classification. Class II (performance standards). [45 FR 60649, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
§ 864.9650 Quality control kit for blood banking reagents.
