Pro-Lab Diagnostics UK

Pro-Lab Diagnostics UK specialises in laboratory reagents and stains used primarily for microbiological and histological testing. Their products include ready-to-use and concentrated solutions like Auramine Phenol, Lugol’s Iodine, and Ziehl-Neelsen Carbol Fuchsin, as well as Gram stain differentiators and other diagnostic reagents. These are designed to support accurate identification and analysis in clinical laboratory settings.

Pro-Lab Diagnostics UK is based in the United Kingdom, which means its devices are subject to EU regulatory frameworks if marketed within the European Economic Area. The company’s products are registered in the EUDAMED database, ensuring compliance with EU requirements for in vitro diagnostics and general laboratory reagents.

Pro-Lab Diagnostics UK’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry tracks manufacturers, devices, and regulatory information to ensure transparency and compliance with EU medical device regulations.

Pro-Lab Diagnostics UK’s products fall under Class A (general laboratory reagents) and IVD General (in vitro diagnostics) classifications. Class A applies to low-risk items like basic reagents, while IVD General covers diagnostic tests used in clinical settings. Classification determines regulatory requirements, with IVD General devices requiring conformity assessment procedures before market placement.