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Idylla™ MSI FFPE Reference Set

SensID GmbH · Model SID-000114 · UDI-DI 04260712780003

NZB
4
510(k) clearances
0
Adverse events
0
Recalls
6
Facilities

Description

Idylla™ MSI FFPE Reference Set is intended as commutable, qualitative control material for microsatellite instability (MSI) markers in FFPE format based on human cell lines. It consists of MSI FFPE MSI-H control with all MSI markers at a frequency of 1x LOD for the Idylla™ MSI Test (refer to Idylla™ MSI Test package insert) and MSI FFPE MSS control with 0% frequency for all MSI markers. This Reference set enables monitoring of the performance, procedures and workflow of laboratory tests using FFPE in combination with the automatic workflow of the Idylla™ platform (Biocartis NV).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.