Lorne Laboratories Ltd

Lorne Laboratories Ltd specialises in monoclonal antibody reagents and enzyme solutions used primarily for blood typing and compatibility testing. Their products include Anti-A, Anti-B, and D-negative control reagents (each in 10ml vials) as well as Papenzyme-Plus, an enzyme reagent for blood grouping procedures. These are classified as In Vitro Diagnostic (IVD) devices, designed to perform tests on human samples outside the body.

Lorne Laboratories Ltd is based in the United Kingdom (GB). As an EU-based manufacturer, its IVD devices are registered in the EU’s centralised database, eudamed, which tracks regulatory information for medical devices across the European Economic Area. This registration is required for compliance with EU IVD regulations, ensuring traceability and transparency for healthcare professionals and authorities.

Lorne Laboratories Ltd’s devices fall under In Vitro Diagnostic (IVD) classifications, specifically IVD Annex II List A (for high-risk devices like certain blood typing reagents) and IVD General (for lower-risk diagnostic products). These classifications determine the regulatory scrutiny and requirements for manufacturing, testing, and market placement, with Annex II List A devices subject to stricter controls due to their critical role in patient safety.

Yes, Lorne Laboratories Ltd’s devices are registered in eudamed, the European Union’s official database for medical devices. This listing is mandatory for IVD manufacturers operating within the EU, as it provides transparent access to device details—such as manufacturer information, classifications, and regulatory status—for healthcare providers, regulators, and patients. It ensures accountability and allows for quick verification of a device’s compliance with EU IVD regulations.