dsDNA-Ab RIA

Primary DI

04049325011373

Basic UDI-DI Code

4049325IVR06020003BR7

Reference

KIPIB19011

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

Radio immunoassay for the quantitative determination of antibodies against double stranded DNA (dsDNA) in adult human serum. The device is intended as an aid in the diagnosis of SLE in patients suspected of Systemic lupus erythematosus (SLE) disease, a systemic and clinically heterogeneous autoimmune disease characterized by autoantibody formation. The presence of anti-dsDNA-Ab is highly characteristic for patients with SLE. It is intended as an aid in the diagnosis of SLE, as well as for antibody quantification before and during disease and as a follow-up/monitoring e.g. of treatments and disease progression. The test kit is intended for manual and professional laboratory use by trained personnel. The test kit is not for home or layperson use.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).