FDA product code QDF: Parathyroid Autofluorescence Detection Device
QDF is the FDA product code for parathyroid autofluorescence detection device. It is a Class II device, regulated under 21 CFR 878.4550 and reviewed by the General and Plastic Surgery panel. Devices under QDF reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
Classification
| Field | Value |
|---|---|
| Device name | Parathyroid Autofluorescence Detection Device |
| Device class | Class II |
| Regulation | 21 CFR 878.4550 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for QDF devices
openFDA lists no recalls for product code QDF.
Frequently asked questions
What is FDA product code QDF?
QDF is the FDA product code for parathyroid autofluorescence detection device. It is a Class II device, regulated under 21 CFR 878.4550 and reviewed by the General and Plastic Surgery panel.
What device class is QDF?
Class II, regulation 21 CFR 878.4550. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QDF
- Run a recall and safety report across every QDF manufacturer
- Watch product code QDF 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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