YouSeq Ltd

YouSeq Ltd specialises in in vitro diagnostic (IVD) molecular testing kits. Their primary product, the YouSeq SARS-CoV-2 Multiplex qRT-PCR kit, is designed for detecting viral RNA in clinical samples using quantitative reverse transcription polymerase chain reaction (qRT-PCR) technology. These devices are intended for laboratory use to identify specific pathogens.

YouSeq Ltd is based in the United Kingdom (GB). The company operates within the European regulatory framework, which is reflected in its device listings and compliance requirements.

YouSeq Ltd’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registry ensures transparency and traceability of devices under the In Vitro Diagnostic Regulation (IVDR).

YouSeq Ltd’s IVD devices fall under Class B (General) classification according to the EU’s In Vitro Diagnostic Regulation (IVDR). This classification is determined based on the intended purpose and risk associated with the device, such as the YouSeq SARS-CoV-2 Multiplex qRT-PCR kit, which is used for detecting viral RNA in clinical samples.