Active-B12 (AB12) Test Kit (Homogeneous Chemiluminescence Immunoassay)

Trade name

Active-B12 (AB12) Test Kit (Homogeneous Chemiluminescence Immunoassay)

UDI-DI code

06974524061790

Basic UDI-DI

B-06974524061790

Reference / catalog number

HCLIA15130

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

This assay is intended for in vitro quantitative determination of Active-B12 in human serum and plasma. The test kit is used as an aid to assessment of vitamin B12 deficiency. For professional and laboratory use only. For in vitro diagnostic use only. Although this product is marketed under the IVDD category in the IVD-Other risk class, it is not eligible for IVDR. According to the classification rules Regulation (EU) 2017/746 it is classified as Class B Rule 6 will be launched on the market. During the transition period for this product, the relevant requirements for IVDR will be met. We pledge that it will be fulfilled.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0102070204VITAMIN B12

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.