Listeria Monocytogenes DNA Detection Kit (Fluorescence PCR Method)
by Suzhou TianLong Biotechnology Co., Ltd. China EUDAMED
Ref P579H
EMDN W0105011305
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06974858560860 | Date26 Jul 2023 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Listeria Monocytogenes DNA Detection Kit (Fluorescence PCR Method)
- Model / Reference
- P579H
- Primary DI / UDI-DI
- 06974858560860
- Basic UDI-DI
- B-06974858560860
- EMDN Code
- W0105011305 Listeria detection by na reagents
- Device Class
- Class IVD General
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000001080
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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 bc71327f-7d3d-4cd6-aab5-9269604dc0b3