BlueDiver Dot Mitochondria2 IgG + IgM

Primary DI

05425023681619

Basic UDI-DI Code

B-05425023681619

Reference

MI2DIV-24

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

D-tek s.a.

BlueDiver Dot LIVER IgG kits are immunodot kits allowing the detection, in human serum, of specific IgG auto-antibodies in the context of an auto-immune hepatitis or Primary Biliary Cirrhosis diagnostic. BlueDiver Dot LIVER IgG kits are intended to be used as confirmatory tests following indirect immunofluorescence assay (IFA), screening and reference method for auto-antibodies detection. The tests are intended for a large, routine population. The kits are strictly reserved for professional use, by trained staff. The kits must be processed on the BlueDiver Instrument.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).