FDA product code QBV

Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

Clinical Chemistry·Class 1·21 CFR 862.2050
US regulatory classifications
US Product Code (FDA)
QBV
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 862.2050
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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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About this record

Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.