21 CFR § 864.9650 Hematology and Pathology Devices

§ 864.9650 Quality control kit for blood banking reagents.

Current through Sep 8, 2026 · Read all of Part 864

(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]

← § 864.9600 Potentiating media for in vitro diagnostic use.§ 864.9700 Blood storage refrigerator and blood storage freezer. →