Anti-Thyroglobulin Antibodies (Anti-TG) Reagent Kit (Chemiluminescent Immunoassay)
by Rayto Life and Analytical Sciences Co., Ltd. China EUDAMED
Ref R13314Model 200 Tests/Kit
EMDN W0102100303
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-R13314ZW | Date16 Jul 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Anti-Thyroglobulin Antibodies (Anti-TG) Reagent Kit (Chemiluminescent Immunoassay)
- Model / Reference
- 200 Tests/Kit, R13314
- Primary DI / UDI-DI
- D-R13314ZW
- Basic UDI-DI
- B-R13314ZW
- EMDN Code
- W0102100303 Thyroglobulin autoantibody
- Device Class
- Class IVD General
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000011141
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 3344b613-76ba-49f5-a6f9-dfc5d3898adb