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Synthetic Next-Generation Sequencing Quality Control And Filler Material

QFI · Not classified · Unknown

Classification

FDA Product Code
QFI
Device class
Not classified
Regulation
Review panel
PA
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
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