BlueDiver Dot Chromatin4 IgG

Primary DI

05425023681817

Basic UDI-DI Code

B-05425023681817

Reference

CHR4DIV-24

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

D-tek s.a.

BlueDiver Dot Chromatin IgG kits are confirmatory immunodot tests allowing the detection, in human serum, of specific anti-nuclear IgG antibodies, following an homogeneous pattern obtained by indirect immunofluorescence assay (IFA), screening and reference method for auto-antibodies detection, in the context of an auto-immune disease diagnostic. 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).