FDA UDI
In Commercial Distribution
🇺🇸 United States
SensID Idylla™ MSI FFPE Reference Set
DI: 04260712780058
·
Model: 2x4
·
SensID GmbH
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SensID Idylla™ MSI FFPE Reference Set
- Primary DI
- 04260712780058
- Version / Model
- 2x4
- Catalog Number
- SID-000114
- Company Name
- SensID GmbH
- Labeler DUNS
- 313586371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-12
- Public Version
- 1
- Public Version Date
- 2023-06-20
- Public Version Status
- New
- Public Device Record Key
- e7b0c971-947e-4a1f-97bd-728761c85605
Device 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).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60094 | Exogenous DNA/RNA internal control IVD, kit | A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260712780058 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius