Respiratory Syncytial Virus Genotype A/B Nucleic Acid Detection Kit (Fluorescence PCR Method)
by Suzhou TianLong Biotechnology Co., Ltd. EUDAMED
Active
Ref P028H
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06974858560549 | Date22 Dec 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Respiratory Syncytial Virus Genotype A/B Nucleic Acid Detection Kit (Fluorescence PCR Method)
- Model / Reference
- P028H
- Primary DI / UDI-DI
- 06974858560549
- Basic UDI-DI
- B-06974858560549
- EMDN Code
- W0105040505 Respiratory syncytial virus (rsv) - 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
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No