Tg (CLIA)
by Maccura Biotechnology Co., Ltd. EUDAMED
Active
Ref IM4408059
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-IM4408059K9 | Date22 May 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Tg (CLIA)
- Model / Reference
- IM4408059
- Primary DI / UDI-DI
- D-IM4408059K9
- Basic UDI-DI
- B-IM4408059K9
- EMDN Code
- W01020408 Thyroglobulin
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Maccura Biotechnology Co., Ltd.
Properties
Other properties (6)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No