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SensID Idylla™ MSI FFPE Reference Set
FDA UDIClass II (US FDA UDI)
by SensID GmbH
Identity
- Trade Name
- SensID 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
- 2x2 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
- 04260712780034 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Exogenous DNA/RNA internal control IVD, kit
SensID Idylla™ MSI FFPE Reference Set by SensID GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 fc626a4d-211c-478e-a4dc-26378cdaff86 35 fields · synced Jun 8, 2026