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SCUClass II

Dna And Rna Oncology Controls

21 CFR 866.5910 / Microbiology
FDA source (opens on fda.gov)

SCU is the FDA product code for Dna And Rna Oncology Controls, a class II device type, regulated under 21 CFR 866.5910. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SCU
Device name
Dna And Rna Oncology Controls
FDA 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.
Regulation
21 CFR 866.5910
Device class
Class II
Review panel
Microbiology
Submission type
510(k) exempt
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