Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
The Centrifuge for Preparation of Cell Concentrate and/or Plasma Concentrate is a laboratory device used to prepare cell concentrate and/or plasma concentrate by separating cells from blood through centrifugation, with labeling that notes the safety and effectiveness of the device for in vivo indications has not been established. It is classified as a Class 1 device under regulation 862.2050, subject to general controls and eligible for third-party review under De Novo classification. The product code is QBV, reviewed by the Hematology (HE) panel. It is not an implant and is not life-sustaining.
Research product code QBV in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QBV
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.