Plasmodium DNA Real Time PCR Kit
by Jiangsu Bioperfectus Technologies Co., Ltd. EUDAMED
Active
Ref JW20102NW-50T
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-JW20102NW-50TE5 | Date13 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- JW20102NW-50T
- Primary DI / UDI-DI
- D-JW20102NW-50TE5
- Basic UDI-DI
- B-JW20102NW-50TE5
- EMDN Code
- W0105050209 Plasmodium (malaria)
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014691
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No