Idylla™ MSI FFPE Reference Set

FDA UDI

Class II (US FDA UDI)

by SensID GmbH

Identity

Trade Name: Idylla™ MSI FFPE Reference Set FDA UDI
Generic Name: Exogenous DNA/RNA internal control IVD, kit FDA UDI
Device Name: 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). FDA UDI
Model / Reference: SID-000114 FDA UDI
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). FDA UDI

Identifiers

Catalog Number: SID-000114 FDA UDI
Primary DI / UDI-DI: 04260712780003 FDA UDI
FDA Product Code: NZB FDA UDI
GMDN Term: Exogenous DNA/RNA internal control IVD, kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Exogenous DNA/RNA internal control IVD, kit

The Idylla MSI FFPE Reference Set is a comprehensive, commutable quality control material for microsatellite instability (MSI) markers in Fragmented Fibroblast Extract (FFPE), providing an ideal tool for laboratory testing. This reference set consists of two MSI-H specific markers with a frequency of 1x LOD and one MSS marker with 0% frequency, enabling the monitoring of performance, procedures, and workflow.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: SensID GmbH

Sources (1)

FDA UDI d64c3e86-dd93-4287-814a-50beabbfddb8 35 fields · synced Jul 12, 2026