Idylla™ Console Software Plus (CSW+)

Organization name

Biocartis NV

SRN

BE-MF-000003661

Manufacturer status

Active

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Trade name

Idylla™ Console Software Plus (CSW+)

UDI-DI code

05415219001178

Basic UDI-DI

5415219P2040HC

Reference / catalog number

P2040

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W02050182NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification