Product code
QFI: Synthetic next-generation sequencing quality control and filler material
FDA product code · Not Classified · Pathology
Key facts
| Product code | QFI |
|---|---|
| Device | Synthetic next-generation sequencing quality control and filler material |
| Device class | Not Classified |
| Review panel | Pathology |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database