Viral DNA and RNA Extraction Kit, Viral DNA and RNA Extraction Kit (Panall 8000 MD System, Pre-filled)
by Xi'an Tianlong Science and Technology Co., Ltd. 9 variants
Ref T340H
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697488477TLH009Z7 06974884777072 | Date15 Aug 2022 | 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- Withdrawn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/IVDR Active
Specification
- Device Name
- Viral DNA and RNA Extraction Kit, Viral DNA and RNA Extraction Kit (Panall 8000 MD System, Pre-filled)
- Model / Reference
- T340H
- Primary DI / UDI-DI
- 06974884777072
- Basic UDI-DI
- 697488477TLH009Z7
- EMDN Code
- W0104080699 Nucleic acid identification (bacteriology) manual / automated - other
- Device Class
- Class A
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000001079
- 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
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No