21 CFR 864.9650 — Kit, Quality Control For Blood Banking Reagents

Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9650

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
KSFKit, Quality Control For Blood Banking Reagents212
PFKQuality Control For Molecular Immunohematology Tests203rd Party
Innolitics

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