GENETIC TESTS - OTHER
Basic Information
- Primary DI
- D-MDM2CEP12FISHCTA3B
- Basic UDI-DI Code
- B-MDM2CEP12FISHCTA3B
- Reference
- MDM2/CEP12 FISH CTA
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- Almac Diagnostic Services Limited
Additional Description
The MDM2/CEP 12 FISH CTA is a qualitative in vitro diagnostic fluorescence in situ hybridization (FISH) assay used to detect MDM2 copy number located at chromosome 12q15. The assay uses formalin-fixed paraffin embedded (FFPE) samples from solid tumour and lymph node resections and biopsies. The Assay is intended to be used for clinical trials evaluating the safety and efficacy of BI 907828. The MDM2/CEP 12 FISH CTA is intended for laboratory professional use only, to be performed only at Almac Diagnostic Servicesโ Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) accredited laboratory located at 19 Seagoe Industrial Estate, BT63 5QD, United Kingdom.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010699 | GENETIC TESTS - OTHER |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).