Beta Amyloid 40 Test Kit (FIA)
by VivaChek Biotech (Hangzhou) Co., Ltd. EUDAMED
Active
Ref VID144-07-011Model VID144
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-VID144EZ | Date1 Nov 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- VID144, VID144-07-011
- Primary DI / UDI-DI
- D-VID144EZ
- Basic UDI-DI
- B-VID144EZ
- EMDN Code
- W0102019013 Beta-amyloid (1-40)
- Device Class
- Class IVD General
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000012160
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties
Show properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No