Gentian GCAL® Calprotectin Calibrator Kit

Organization name

Gentian AS

SRN

NO-MF-000003448

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CW043

  EUDAMED did not publish a description for this code.
• CW083

  EUDAMED did not publish a description for this code.
• CW082

  EUDAMED did not publish a description for this code.
• CW085

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Norway; available across 23 countries total.

Trade name

Gentian GCAL® Calprotectin Calibrator Kit

UDI-DI code

07090038460191

Basic UDI-DI

9003846B02GCAL002DY

Reference / catalog number

1251

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The calibrator kit consists of 6 calibrator levels (6x1 ml)

Additional information URL

https://www.gentian.com/products/ifu

Clinical sizes

No clinical sizes registered for this device.

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

• W0102152203SPECIFIC PROTEIN STANDARDS AND CALIBRATORS