AB Diagnostic Systems GmbH

AB Diagnostic Systems GmbH specializes in in vitro diagnostic (IVD) immunoassay devices. These are laboratory tests designed to detect specific biomarkers in blood or serum samples, such as thyroid-stimulating hormone (TSH), hepatitis B surface antigen (HBs Ag), hepatitis E virus antibodies (HEV IgG/IgM), HIV antigens/antibodies (AgAb), and total immunoglobulin E (IgE). The devices help clinicians make diagnostic decisions by providing quantitative or qualitative results.

The company is headquartered in Germany, as indicated by its registration details. This location aligns with its compliance requirements under EU regulatory frameworks, including the EU In Vitro Diagnostic Regulation (IVDR).

AB Diagnostic Systems GmbH’s devices are registered in the eudamed database, which is the official EU repository for in vitro diagnostic (IVD) manufacturers and their products. Registration in eudamed is mandatory under EU regulatory requirements to ensure transparency and traceability of IVD devices.

The company’s IVD devices fall under two classification categories under the EU In Vitro Diagnostic Regulation (IVDR): Annex II List A (high-risk devices) and General (lower-risk) classifications. The classification depends on factors like the device’s intended use, potential health risks, and the nature of the biomarkers being tested. Annex II List A includes devices with significant health implications, while General classification applies to lower-risk tests.