1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES
  6. Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products
  7. 21 CFR § 864.9650
21 CFR § 864.9650
Quality control kit for blood banking reagents
June 25, 2020
CFR

(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]

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

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