Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)
by Daan Gene Co., Ltd. China EUDAMED
Ref DA1142Model Single tube, 20 tests/kit EMDN W0105010117
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06928103011423 | Date3 Jan 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)
- Model / Reference
- Single tube, 20 tests/kit, DA1142
- Primary DI / UDI-DI
- 06928103011423
- Basic UDI-DI
- B-06928103011423
- EMDN Code
- W0105010117 Chlamydia trachomatis detection by na reagents
- Device Class
- Class IVD Annex II List B
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000025799
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Daan Gene Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED ed97fb10-eed2-47da-9e10-10e0f64bb1fa