510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QFINot classified

Synthetic Next-Generation Sequencing Quality Control And Filler Material

Unknown
FDA source (opens on fda.gov)

QFI is the FDA product code for Synthetic Next-Generation Sequencing Quality Control And Filler Material. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QFI
Device name
Synthetic Next-Generation Sequencing Quality Control And Filler Material
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
Contact ODE
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code