BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)
by Xiamen Spacegen Co., Ltd. China EUDAMED
Ref Lotus NL B.V. Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected] EMDN W010699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06972665700110 | Date21 Sep 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- Lotus NL B.V. Address：Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. Email：[email protected]
- Primary DI / UDI-DI
- 06972665700110
- Basic UDI-DI
- B-06972665700110
- EMDN Code
- W010699 Genetic tests - other
- Device Class
- Class IVD General
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000018018
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Xiamen Spacegen Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED b6003634-4608-4aa3-b94b-5406636a016c