Advanced Practical Diagnostics

Advanced Practical Diagnostics specializes in in vitro diagnostic (IVD) medical devices, specifically enzyme-linked immunosorbent assay (ELISA) kits and MAIPA (Membrane Antigen ImmunoPrecipitation Assay) kits. Their products are designed to detect anti-drug antibodies and specific monoclonal antibodies, such as those targeting adalimumab, ustekinumab, golimumab, secukinumab, infliximab, and vedolizumab. These assays help in monitoring therapeutic drug levels and immune responses in patients.

Advanced Practical Diagnostics is headquartered in Belgium. The company’s location in Belgium places it within the European Union, which influences its regulatory compliance and participation in EU-wide databases like eudamed.

Advanced Practical Diagnostics’ devices are listed in the EU’s eudamed database, which is the official European Union registry for medical devices. This registry ensures transparency and traceability of IVD devices authorized for use within the EU, including those classified under the Medical Device Regulation (MDR).

Advanced Practical Diagnostics’ devices are classified as Class B and Class C in vitro diagnostic medical devices. Classification is determined by factors like the intended use, risk to patient health, and the potential for harm if the device performs incorrectly. Class B devices pose moderate risk, while Class C devices carry a higher risk, often due to their critical role in diagnosis or patient management.