EGFR/KRAS/ALK Gene Mutation Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method)
by Bgi Europe a/S Denmark EUDAMED
Ref MFG030014Model 48T EMDN W01060299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05745000468836 | Date26 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- EGFR/KRAS/ALK Gene Mutation Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method)
- Model / Reference
- 48T, MFG030014
- Primary DI / UDI-DI
- 05745000468836
- Basic UDI-DI
- B-05745000468836
- EMDN Code
- W01060299 Tests for acquired genetic or chromosomal alterations - other
- Device Class
- Class IVD General
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000014089
Other devices from Bgi Europe a/S
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED fa3f6fc3-1a8f-4e81-8897-9a61e01642ce