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TruSight™ Oncology DNA Control v2
The TruSight Oncology DNA Control v2 and TruSight Oncology RNA Control v2 are control materials sold separately for use as a quality control to monitor analytical performance of the library preparation, sequencing, and analysis steps of Next Generation Sequencing based molecular diagnostic assays used for the detection of select DNA and RNA variants.
Details
Device typeCancer-related multiple gene mutation profile IVD, control: A material which is used to verify the performance of an assay intended to be used for genomic profiling/screening of multiple genes associated with cancer to detect specific types of mutations [e.g., single nucleotide variants (SNVs), insertions, deletions, fusions, translocations and/or copy number variations (CNVs)] in a clinical specimen.
FDA categoryDna And Rna Oncology Controls
Device ID00816270020873
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information