§ 864.9650. Quality control kit for blood banking reagents.
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/us/cfr/t21/s§ 864.9650·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]