QBV — Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate Class I
Classification Details
- Product Code
- QBV
- Device Class
- Class I
- Regulation Number
- 862.2050
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.