Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05415219000126
- Basic UDI-DI Code
- 5415219P1010GU
- Reference
- P1010
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Biocartis NV
Additional Description
The Idylla™ System is an in vitro diagnostic (IVD) medical device, consisting of the Idylla™ Console and the Idylla™ Instrument(s). The System is intended for the detection of nucleic acid targets in various types of human samples, using disposable Test specific Idylla™ cartridges. Idylla™ covers the entire process from sample to result, including for example liquefaction, cell lysis, DNA/RNA extraction, real-time amplification/detection, and data analysis and reporting.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02050116 | NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS |
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