Nucleic Acid Extraction Kit
by Daan Gene Co., Ltd. 13 variants
Ref DA0600
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 | Number69281030060XER 06928103006009 | Date30 Oct 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- Withdrawn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
- Nucleic Acid Extraction Kit
- Model / Reference
- DA0600
- Primary DI / UDI-DI
- 06928103006009
- Basic UDI-DI
- 69281030060XER
- EMDN Code
- W0599 IVD general use consumable devices - other
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000025799
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Daan Gene Co., Ltd.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No