Immunodiagnostic Systems Limited

Immunodiagnostic Systems Limited specialises in in vitro diagnostic (IVD) reagents and kits. These include solutions for detecting rheumatoid arthritis markers like the Zenit RA D-Sorb, hormone assays such as the Androstenedione test, vitamin D measurement kits like the IDS-iSYS 25 VitDS, and a variety of specific IgE test kits for identifying allergies to foods (e.g., cow’s milk, pistachio, soybean) and environmental allergens (e.g., meadow fescue, rye-grass). The company also produces control sets and calibrator reagents for laboratory use.

The company is headquartered in the United Kingdom. Its location is relevant for regulatory compliance and transparency, as it operates within the EU’s medical device framework, which includes obligations like listing devices in Eudamed.

The company’s devices are listed in the European Database on Medical Devices (Eudamed), which is the official EU registry for tracking medical devices authorised under the Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). Listing in Eudamed ensures traceability and compliance with EU requirements.

The company’s products fall into Class A, Class B, and IVD General classifications. Class A devices are typically low-risk, non-invasive diagnostics like some reagent kits, while Class B includes moderate-risk assays such as specific IgE tests for allergens. IVD General refers to devices not fitting into specific risk classes but still requiring regulatory oversight. Classification determines the level of scrutiny and documentation required for authorisation.

Listing in Eudamed ensures transparency and compliance with EU medical device laws. It allows healthcare professionals, regulators, and authorities to verify that the devices meet legal requirements before use. For example, specific IgE test kits (like those for cow’s milk or rye-grass allergies) must be traceable to confirm their safety and performance, which Eudamed facilitates. This registry also supports post-market surveillance and recall procedures if needed.