MP Diagnostics TP ELISA 4.0
by MP Biomedicals Asia Pacific Pte Ltd United States EUDAMED
Ref 23560-480Model 23560-480 (480 Tests/ kit) EMDN W0105010302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08887581001068 | Date13 Apr 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- 23560-480 (480 Tests/ kit), 23560-480
- Primary DI / UDI-DI
- 08887581001068
- Basic UDI-DI
- B-08887581001068
- EMDN Code
- W0105010302 Syphilis antibody assays total
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- SG-MF-000024819
- Authorised representative
- MP Biomedicals Germany GmbH DE-AR-000020992
Other devices from MP Biomedicals Asia Pacific Pte Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 069cab83-9e93-42ad-81cf-b122cc44e46c