FDA product code LQI: Hepatitis Delta Serological Reagents
LQI is the FDA product code for hepatitis delta serological reagents. It is a Class III device, reviewed by the Microbiology panel. Devices under LQI reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Hepatitis Delta Serological Reagents |
| Device class | Class III |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LQI devices
openFDA lists no recalls for product code LQI.
Frequently asked questions
What is FDA product code LQI?
LQI is the FDA product code for hepatitis delta serological reagents. It is a Class III device, reviewed by the Microbiology panel.
What device class is LQI?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LQI
- Run a recall and safety report across every LQI manufacturer
- Watch product code LQI 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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