Respiratory 17 Types Pathogen Multiplex Nucleic Acid Detection Kit - Respiratory 17 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method
by Suzhou TianLong Biotechnology Co., Ltd.
Ref P764H
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-06974858560792 06974858560792 | Date26 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- Withdrawn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
- Device Name
- Respiratory 17 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method; Freeze-dried)
- Model / Reference
- P764H
- Primary DI / UDI-DI
- 06974858560792
- Basic UDI-DI
- B-06974858560792
- EMDN Code
- W0105070503 Respiratory tract infections - multiplex na reagents
- Models / Variants
- Respiratory 17 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method
- Device Class
- Class IVD General
- EU 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 (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