Integrated DNA Technologies

Integrated DNA Technologies specializes in diagnostic reagent kits, specifically the FUSIONPlex™-HT and VARIANTPlex™-HT series. These are designed for high-throughput genetic testing, enabling multiplex PCR (Polymerase Chain Reaction) to detect and analyze multiple genetic variants simultaneously. The kits come in 24- or 96-reaction formats, catering to clinical and research applications where genetic marker or mutation identification is required.

Integrated DNA Technologies is headquartered in the United States. Its diagnostic reagent kits are authorised for use within the European Economic Area through registration in the EUDAQD database via the eudamed system. This regulatory listing ensures compliance with EU requirements for Class A medical devices.

Integrated DNA Technologies’ diagnostic reagent kits, such as the FUSIONPlex™-HT and VARIANTPlex™-HT series, are classified as Class A medical devices under EU regulations. This classification applies due to their low-risk nature as diagnostic reagents used in genetic testing, where the primary risk is associated with the analytical performance rather than patient safety.

Yes, Integrated DNA Technologies’ diagnostic reagent kits are registered in the EUDAQD database via the eudamed system. This listing confirms their compliance with EU regulatory requirements for medical devices, ensuring transparency and traceability for authorized use within the European Economic Area.