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U.S. Department of Health and Human Services

Product Classification
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Device synthetic next-generation sequencing quality control and filler material
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.
Physical State The reagent includes synthetic DNA sequences.
Technical Method The material is a synthetic sequence material which can be added to sample pools immediately prior to loading the sequencer to allow sequencing runs to be processed that do not have a sufficient number of patient samples. The material may also be used to quality control sequencing metrics.
Target Area Not applicable.
Review Panel Pathology
Product CodeQFI
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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