QBV

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

Device class

Class I (low risk)

Regulation

21 CFR 862.2050

Medical specialty

Clinical Chemistry

Flags

Third-party review eligible

FDA 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.

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