Product code SCU

Device name
Dna And Rna Oncology Controls
Medical specialty
Microbiology
Device class
2
Regulation number
866.5910
Review panel
MG
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Oncology controls are a device intended for use in a next generation sequencing (NGS)-based in vitro diagnostic test system as a quality control to monitor analytical performance of the library preparation, sequencing, and analysis steps of the workflow by detecting systematic analytical deviations that may arise from reagent or instrument variation. This type of device includes synthetic DNA and RNA controls.
Source
FDA openFDA device classification dataset