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Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

FDA product code QBV · 2 cleared devices

Class 1 Clinical Chemistry
Regulation
21 CFR 862.2050
Review panel
HE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2026-04-02 – 2026-04-02

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.

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