Orphée SA

Orphée SA specializes in diagnostic reagents and controls used for in vitro diagnostic (IVD) testing. Their portfolio includes lytic solutions (such as cyanide-free options), diluents, calibration standards, and controls for analyzing clinical markers like CRP (C-reactive protein). These products are designed to support blood sample preparation and clinical chemistry assays, ensuring accurate diagnostic results.

Orphée SA is headquartered in Switzerland. As a manufacturer of in vitro diagnostic devices, their products are subject to European Union regulatory requirements, including those outlined in the In Vitro Diagnostic Regulation (IVDR). Their devices are listed in the EU’s official eudamed registry, demonstrating compliance with EU regulatory processes.

Orphée SA’s devices are classified under Class A (low-risk IVDs) and IVD General categories. Classification is determined by factors like intended use, risk to patient health, and the potential for misdiagnosis. For example, lytic solutions and diluents are typically low-risk, while certain controls or reagents may require closer scrutiny depending on their role in diagnostic accuracy.

Yes, Orphée SA’s devices are listed in eudamed, the European Union’s official database for in vitro diagnostic medical devices. This registry is maintained under the IVDR and provides transparency on manufacturers, devices, and their regulatory status within the EU. Listing confirms the devices meet EU requirements for market placement.

Orphée SA’s products are primarily used in laboratory settings to prepare blood samples and support diagnostic testing. For instance, their Mythic 18 Cyanide-free Lytic solution helps lyse red blood cells without cyanide, enabling clearer analysis of plasma markers like CRP. Controls (e.g., MYTHIC CRP Controls) are used to validate the performance of diagnostic assays, ensuring accuracy and reliability in clinical chemistry tests.