Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay
by Seegene, Inc. FDA registration: South Korea EUDAMED
Ref RV10259X EMDN W0105070304
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08809240103036 | Date14 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- RV10259X
- Primary DI / UDI-DI
- 08809240103036
- Basic UDI-DI
- B-08809240103036
- EMDN Code
- W0105070304 Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex na reagents
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000022275
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Seegene Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 7fe159c3-0c67-4ee3-bda3-ff29b85e98fe