Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescent Probe)
by Triplex International Biosciences (China) Co., LTD. China EUDAMED
Ref C011942 EMDN W01050499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06950917910609 | Date27 Oct 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescent Probe)
- Model / Reference
- C011942
- Primary DI / UDI-DI
- 06950917910609
- Basic UDI-DI
- B-06950917910609
- EMDN Code
- W01050499 Virology reagents - other
- Device Class
- Class IVD General
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000001097
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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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 b8545da8-c280-4438-9548-d09f905f4485