QYC — Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions Class II
FDA product code QYC covers "Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions", a Class II medical device regulated under 21 CFR 864.9115. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- QYC
- Device Class
- Class II
- Regulation Number
- 864.9115
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
The container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment.