Centrifuge for Preparation of Cell Concentrate And/Or Plasma Concentrate

What Is This Device?

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.

How Is QBV Classified?

Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate is FDA product code QBV, Class 1, 21 CFR 862.2050.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.