Influenza A/Influenza B/Respiratory Syncytial Virus (RSV) Nucleic Acid Detection Kit (Fluorescence PCR Method-0.1mL Pre-filled)
by Suzhou TianLong Biotechnology Co., Ltd.
Ref YP1004H, IS-FZ-034-24-2Model 24 tests/kit Sampling tube with 2.5mL Lysis Buffer
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06974858560747 | Date12 Jul 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Trade Name
- Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA)
- Device Name
- Influenza A/Influenza B/Respiratory Syncytial Virus (RSV) Nucleic Acid Detection Kit (Fluorescence PCR Method-0.1mL Pre-filled)
- Model / Reference
- YP1004H, 24 tests/kit Sampling tube with 2.5mL Lysis Buffer, IS-FZ-034-24-2
- Primary DI / UDI-DI
- 06974858560747, 06974677694623
- Basic UDI-DI
- B-06974858560747, B-06974677694623
- EMDN Code
- W0105040504 Influenza & para influenza - na reagents
- Device Class
- Class IVD General
- EU market of registration
- ItalySpain
Manufacturer details
- EUDAMED SRN
- CN-MF-000001080
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
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