FDA product code QIX: System, Transdermal Delivery, Cder Or Cber Led
QIX is the FDA product code for system, transdermal delivery, cder or cber led. It is a Not classified device, reviewed by the General Hospital panel. Devices under QIX reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Drug delivery systems designed to deliver at least one therapeutically active ingredient (drug substance) across the skin for systemic effect.
Classification
| Field | Value |
|---|---|
| Device name | System, Transdermal Delivery, Cder Or Cber Led |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for QIX devices
openFDA lists no recalls for product code QIX.
Frequently asked questions
What is FDA product code QIX?
QIX is the FDA product code for system, transdermal delivery, cder or cber led. It is a Not classified device, reviewed by the General Hospital panel.
What device class is QIX?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QIX
- Run a recall and safety report across every QIX manufacturer
- Watch product code QIX 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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