Diagam S.A.

Diagam S.A. specializes in in vitro diagnostic (IVD) reagents and associated control and calibrator kits. Their products include assays for detecting biomarkers like Rheumatoid Factor, Antistreptolysin O, Albumin (for urine and cerebrospinal fluid), and Retinol Binding Protein. These are designed for laboratory use to aid in diagnosing or monitoring specific medical conditions.

Diagam S.A. is headquartered in Belgium. The company’s location in Belgium aligns with EU regulatory frameworks, which may influence its compliance and reporting processes for its diagnostic devices.

Diagam S.A.’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry is used to track device manufacturers, their products, and relevant regulatory information under EU regulations like IVDR (In Vitro Diagnostic Regulation).

Diagam S.A.’s products fall under the IVD General classification category. This classification applies to most in vitro diagnostic medical devices, including reagents, controls, and calibrators, which are intended for general diagnostic use in laboratories. The classification determines regulatory requirements, such as conformity assessment procedures, but does not imply approval—only that the devices must comply with EU IVDR standards.