SERCON LIMITED

Sercon Limited specializes in mass spectrometry analysers classified as in vitro diagnostic (IVD) devices. These instruments are engineered to analyze biochemical and chemical compositions, commonly used in clinical or research environments for tasks like drug monitoring, toxicology screening, and metabolic studies. The focus is on high-precision analytical tools for diagnostic purposes.

Sercon Limited is based in the United States. Since its devices fall under U.S. regulatory jurisdiction, they must comply with FDA requirements. The company’s mass spectrometry analysers are categorized as Class I devices, which typically involve lower-risk products but still require adherence to manufacturing and labeling standards to ensure safety and performance.

Yes, Sercon Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to verify the identity and history of the devices. Listing in the UDI system is a key requirement for Class I devices in the U.S., supporting compliance and market tracking.

Sercon Limited’s mass spectrometry analysers are classified as Class I devices under U.S. regulations. This classification is based on their intended use as low-risk diagnostic tools, where the risk to patients is minimal. Class I devices generally require compliance with general controls (e.g., proper labeling, manufacturing practices) but do not typically necessitate pre-market approval or rigorous clinical trials, as the focus remains on ensuring safe and effective performance.