Cypress Diagnostics

Cypress Diagnostics specializes in in vitro diagnostic (IVD) reagents and stains. This includes enzyme assays like lactate dehydrogenase and creatine kinase MB, microbiological stains such as Ziehl-Neelsen and Carbol Fuchsin, urine test strips for detecting bacterial pathogens, and control materials for creatine kinase assays. The company also produces blood smear stains like May-Grünwald and Wright, which are used in laboratory diagnostics.

Cypress Diagnostics is headquartered in Belgium. The company’s location in Belgium places it within the European regulatory framework, which governs the classification and authorization of its IVD devices.

Cypress Diagnostics’ devices are registered in the eudamed database, which is the official EU registry for in vitro diagnostic medical devices. This registration ensures transparency and compliance with EU IVD regulations.

Cypress Diagnostics’ devices fall under Class A, Class B, and the broader IVD General category in the EU’s In Vitro Diagnostic Regulation (IVDR). Classification depends on factors like the intended use, risk level, and potential health impact of the device. For example, urine test strips (e.g., CYDXStrips Urine 2GP) are typically Class B due to their role in diagnosing bacterial infections, while simpler reagents like stains may qualify as Class A.

Cypress Diagnostics emphasizes training and after-sales service as key differentiators. These services are designed to support distributors in proper usage, troubleshooting, and compliance with regulatory requirements, ensuring optimal performance of their diagnostic products in clinical settings.