Poly Diagnostics Entamoeba histolytica, RNase P Real-Time PCR kit
by Poly Diagnostics Luxembourg EUDAMED
Ref PD163L96
EMDN W0105070504
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number5430004263PD163GH | Date21 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Poly Diagnostics Entamoeba histolytica, RNase P Real-Time PCR kit
- Model / Reference
- PD163L96
- Primary DI / UDI-DI
- 05430005087280
- Basic UDI-DI
- 5430004263PD163GH
- EMDN Code
- W0105070504 Gastrointestinal infections - multiplex na reagents
- Device Class
- Class B
- Market of Registration
- Luxembourg
Manufacturer details
- EUDAMED SRN
- LU-MF-000042647
Other devices from Poly Diagnostics
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
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 05430005087280|5430004263PD163GH