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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device centrifuge for preparation of cell concentrate and/or plasma concentrate
Regulation Description General purpose laboratory equipment labeled or promoted for a specific medical use.
Definition To prepare cell concentrate and/or plasma concentrate by separating cells through centrifugation. Contraindications - Labeling Warnings and Precautions: The safety and effectiveness of this device for in vivo indications for use has not been established.
Product CodeQBV
Regulation Number 862.2050
Device Class 1

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