GCAL®NEPH Controls

Organization name

Gentian AS

SRN

NO-MF-000003448

Manufacturer status

Active

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

• CW043

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

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

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

  EUDAMED did not publish a description for this code.

Primary placement in Norway; available across 24 countries total.

Trade name

GCAL®NEPH Controls

UDI-DI code

07090038460221

Basic UDI-DI

9003846B02GCAL003E2

Reference / catalog number

1719

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 control kit consists of 3 x 1.1 ml Control Low + 3 x 1.1 ml Control High

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.

• W0102152003SPECIFIC PROTEIN CONTROLS