FDA product code QYC: Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions
QYC is the FDA product code for container system for the processing and storage of red blood cell components under reduced oxygen conditions. It is a Class II device, regulated under 21 CFR 864.9115 and reviewed by the Hematology panel. Devices under QYC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions |
| Device class | Class II |
| Regulation | 21 CFR 864.9115 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for QYC devices
openFDA lists no recalls for product code QYC.
Frequently asked questions
What is FDA product code QYC?
QYC is the FDA product code for container system for the processing and storage of red blood cell components under reduced oxygen conditions. It is a Class II device, regulated under 21 CFR 864.9115 and reviewed by the Hematology panel.
What device class is QYC?
Class II, regulation 21 CFR 864.9115. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QYC
- Run a recall and safety report across every QYC manufacturer
- Watch product code QYC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.