FDA product code QFI: Synthetic Next-Generation Sequencing Quality Control And Filler Material
QFI is the FDA product code for synthetic next-generation sequencing quality control and filler material. It is a Not classified device, reviewed by the Pathology panel. Devices under QFI reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
A synthetic next-generation sequencing filler material which contains an adapter-ligated library which allows users to run partial batches of next-generation sequencing assays by adding the material to sample pools to fill in for incomplete batched runs.
Classification
| Field | Value |
|---|---|
| Device name | Synthetic Next-Generation Sequencing Quality Control And Filler Material |
| Device class | Not classified |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for QFI devices
openFDA lists no recalls for product code QFI.
Frequently asked questions
What is FDA product code QFI?
QFI is the FDA product code for synthetic next-generation sequencing quality control and filler material. It is a Not classified device, reviewed by the Pathology panel.
What device class is QFI?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QFI
- Run a recall and safety report across every QFI manufacturer
- Watch product code QFI 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.