QBV — Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate Class I
FDA product code QBV covers "Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate", a Class I medical device regulated under 21 CFR 862.2050. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.
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.