Salmonella Paratyphi Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
by Sansure Biotech Inc. United States EUDAMED
Ref S3234E-24
EMDN W0105011003
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-06955792735156 | Date1 Sep 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Salmonella Paratyphi Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
- Model / Reference
- S3234E-24
- Primary DI / UDI-DI
- 06955792735156
- Basic UDI-DI
- B-06955792735156
- EMDN Code
- W0105011003 Salmonella detection by na reagents
- Device Class
- Class IVD General
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000011392
- Authorised representative
- Obelis s.a. BE-AR-000000106
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 18fe5a00-4414-48cc-83c6-e9154ad3f23d