FDA product code QSH: Coronavirus Marker Detection
QSH is the FDA product code for coronavirus marker detection. It is a Not classified device, reviewed by the Microbiology panel. Devices under QSH reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Coronavirus marker detection
Classification
| Field | Value |
|---|---|
| Device name | Coronavirus Marker Detection |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QSH devices
openFDA lists no recalls for product code QSH.
Frequently asked questions
What is FDA product code QSH?
QSH is the FDA product code for coronavirus marker detection. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QSH?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QSH
- Run a recall and safety report across every QSH manufacturer
- Watch product code QSH 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.