Fisher Diagnostics A division of Fisher Scientific Company, LLC

Fisher Diagnostics specializes in in vitro diagnostic (IVD) coagulation control plasmas and reagents. These include products like the Pacific Hemostasis® APTT-XL for activated partial thromboplastin time (APTT) testing, high-fibrinogen control plasma, and thromboplastin-D for prothrombin time assessments. These devices are designed for laboratory use to monitor blood clotting parameters and ensure the accuracy of coagulation assays.

Fisher Diagnostics is based in the United States as a division of Fisher Scientific Company, LLC. While the company’s headquarters are in the US, its IVD devices are registered in the EUDAMED database, indicating compliance with European Union regulatory requirements. This registration reflects the company’s participation in the EU’s medical device regulatory framework, though individual devices must undergo their own authorization processes.

Fisher Diagnostics’ devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This inclusion is required for IVD devices classified under the EU’s regulatory framework, specifically those falling under the 'IVD General' category. EUDAMED ensures transparency and traceability of devices marketed within the EU, allowing healthcare professionals and regulators to verify compliance and device details.

Fisher Diagnostics’ IVD devices are classified under the EU’s 'Class B' category for in vitro diagnostics. This classification is determined by factors like the risk associated with the device’s use—for example, coagulation control plasmas and reagents carry moderate risk due to their role in critical laboratory testing. Class B devices require conformity assessment procedures, including technical documentation and EU conformity assessment by a Notified Body, but they do not pose the highest risk levels seen in Class C or D devices.