QFI — Synthetic Next-Generation Sequencing Quality Control And Filler Material Class N

FDA Device Classification

FDA product code QFI covers "Synthetic Next-Generation Sequencing Quality Control And Filler Material", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code
QFI
Device Class
Class N
Regulation Number
Submission Type
Review Panel
PA
Medical Specialty
Unknown
Implant
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.