21 C.F.R. § 864.9650

Current through November 30, 2024
Section 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).

21 C.F.R. §864.9650

45 FR 60649, Sept. 12, 1980