Procalcitonin (PCT) test kit (fluorescence immunochromatography)
by Sanqi Biomedical(Shandong)Co., Ltd. China EUDAMED
Ref 4973Model 3Q-FA1000 EMDN W0102069013
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697447273034MQ | Date7 Jun 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 3Q-FA1000, 4973
- Primary DI / UDI-DI
- 06974472730342, 06974472730298, 06974472730304, 06974472730281, 06974472730311, 06974472730328, 06974472730335
- Basic UDI-DI
- 697447273034MQ, 697447273029MX, 697447273030MG, 697447273028MV, 697447273031MJ, 697447273032ML, 697447273033MN
- EMDN Code
- W0102069013 Procalcitonin
- Device Class
- Class A
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000030641
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Sanqi Biomedical(Shandong)Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Surgical Instrument: No
- New Device: No
Sources (7)
- EUDAMED 5049544e-73b0-456b-8bfc-c16c2b5db345
- EUDAMED 06974472730298|697447273029MX
- EUDAMED 06974472730304|697447273030MG
- EUDAMED 06974472730281|697447273028MV
- EUDAMED 06974472730311|697447273031MJ
- EUDAMED 06974472730328|697447273032ML
- EUDAMED 06974472730335|697447273033MN