864.9650 Quality control kit for blood banking reagents.§ 864.9650 Quality control kit for blood banking reagents.
(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]