BlueDiver Dot Milk Intolerance IgG

Primary DI

05425023681381

Basic UDI-DI Code

B-05425023681381

Reference

BSDIV-24

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

D-tek s.a.

BlueDiver Dot Milk intolerance kits are immunodot kits allowing the detection, in human serum, of specific IgG auto-antibodies in the context of a milk intolerance diagnostic. BlueDiver Dot Milk intolerance kits are intended to be used as confirmatory tests following other screening enzyme immunoassay (EIA), considered as reference method for anti-betalactoglobulin or anti-soya 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).