Eu Ivdr
Eu Ivd Class A
On The Market
🇧🇪 Belgium
Idylla™ Console Software Plus (CSW+)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05415219001178
- Basic UDI-DI Code
- 5415219P2040HC
- Reference
- P2040
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Biocartis NV
Additional Description
For in vitro diagnostic use. For professional use only. Idylla™ Console Software Plus (CSW+) is a software application for use with the Idylla™ System. The software is used to initiate a Test Request and to generate a Test Result Report for supported Idylla™ Tests and Assays. Results for each Test or Assay are reported in accordance with the specific intended purpose of the individual Test or Assay.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02050182 | NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES |
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