GENEDRIVE DIAGNOSTICS LTD

Genedrive Diagnostics Ltd specialises in in vitro diagnostic (IVD) devices, primarily nucleic acid testing kits and systems. Their portfolio includes SARS-CoV-2 detection kits using nucleic acid techniques (NAT), as well as genetic identification and control kits like those for CYP2C19 genotyping and MT-RNR1 testing. These products are designed for molecular analysis in clinical and research settings.

Genedrive Diagnostics Ltd is based in the United Kingdom. As a UK-based manufacturer, its devices must comply with both EU and U.S. regulatory standards. The company’s products are registered in the EU’s EUDAMED database and listed in the FDA’s Unique Device Identifier (UDI) system, demonstrating adherence to European IVD regulations and U.S. requirements for medical devices.

Genedrive Diagnostics Ltd’s devices are listed in two key regulatory registries: the EU’s EUDAMED database, which tracks In Vitro Diagnostic Medical Devices across the European Union, and the FDA’s Unique Device Identifier (UDI) system in the United States. These listings reflect compliance with respective regulatory frameworks for IVDs.

Under EU In Vitro Diagnostic Regulation (IVDR), Genedrive Diagnostics Ltd’s devices fall into multiple classification categories: primarily Class A for low-risk general IVDs (e.g., some genetic control kits) and Class C for higher-risk devices like SARS-CoV-2 nucleic acid testing kits. Some products also qualify under the IVD General and Non-Invasive (N) classifications, depending on their intended use and risk profile.

Beyond SARS-CoV-2 detection kits, Genedrive Diagnostics Ltd manufactures diagnostic tools for genetic analysis, including CYP2C19 genotyping kits (used for pharmacogenetic testing) and MT-RNR1 control/identification kits (for validation and quality control in molecular diagnostics). These products expand into areas like personalised medicine and laboratory validation, complementing their nucleic acid testing systems.