BlueDiver Quantrix Liver10 IgG
by D-tek s.a. Belgium EUDAMED
Ref LI10Q-24, LIVER10QModel 542502368BDQANA3C, BlueDiver Quantrix Liver EMDN W0102100101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05425023682067 | Date12 Aug 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Trade Name
- BlueDiver Quantrix Liver10 IgGBlueDiver Quantrix Liver 10 IgG
- Device Name
- BlueDiver Quantrix ANA
- Model / Reference
- 542502368BDQANA3C, LI10Q-24, BlueDiver Quantrix Liver, LIVER10Q
- Primary DI / UDI-DI
- 05425023682067
- Basic UDI-DI
- B-05425023682067, 542502368BDQLIVERQV
- Direct Marketing DI
- 05425023682067
- EMDN Code
- W0102100101, W0102100703
- Device Class
- Class IVD GeneralClass B
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000024530
Other devices from D-tek s.a.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED bddd9324-6939-40a3-b0ad-5047c529dc49
- EUDAMED 05425023682067|542502368BDQLIVERQV