Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
Medical specialty
Clinical Chemistry
Device class
1
Regulation number
862.2050
Review panel
HE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Ineligible
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.