2cxINC01

Organization name

2cureX A/S

SRN

DK-MF-000036335

Manufacturer status

Active

Primary placement in Denmark; available across 32 countries total.

Trade name

not provided

UDI-DI code

29418000002cxINC

Basic UDI-DI

2321183242cxINC6J

Reference / catalog number

2cxINC01

Issuing entity

ICCBBA

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

As part of the IndiTreat® CRC testing, IndiNet CRC is an in vitro diagnostic software used to determine tumor growth inhibition induced by specific antineoplastic drugs of patient derived 3D microtumors from fresh non- fixated samples of colorectal cancer (CRC) tissue. IndiNet CRC is image analysis software, designed to identify and quantify living tumoroids based on bright field images and images of tumoroids stained with IndiTreat® Live Stain. Patient specific tumor growth inhibition by effective cancer drug regimen is derived using the IndiTreat® Live Stain assay in combination with the IndiNet CRC algorithm and the results are compared with a reference database. This information can be used to classify the tumor sensitivity / susceptibility to treatment with a variety of antineoplastic drugs and may be used by physicians for treatment planning. IndiNet CRC is intended for use by qualified personnel trained by 2cureX. Users should have a thorough understanding of IndiTreat® CRC testing. Familiarity with basic image analysis tools and concepts is recommended.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

29418000002cxINC

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W02069092VARIOUS SAMPLE PROCESSING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE