FDA product code QGU: Hemoglobin For Donor Testing
QGU is the FDA product code for hemoglobin for donor testing. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel. Devices under QGU reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Assays hemoglobin concentration test for blood donors.
Classification
| Field | Value |
|---|---|
| Device name | Hemoglobin For Donor Testing |
| Device class | Class II |
| Regulation | 21 CFR 864.7500 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for QGU devices
openFDA lists no recalls for product code QGU.
Frequently asked questions
What is FDA product code QGU?
QGU is the FDA product code for hemoglobin for donor testing. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel.
What device class is QGU?
Class II, regulation 21 CFR 864.7500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QGU
- Run a recall and safety report across every QGU manufacturer
- Watch product code QGU 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.
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