Gold Standard Diagnostics Frankfurt GmbH

Gold Standard Diagnostics Frankfurt GmbH specializes in in-vitro diagnostic (IVD) reagents and substrates designed for serological testing. Their portfolio includes immunoassay conjugates (such as IgG, IgA, and IgM conjugates), dilution/wash buffers, stopping solutions, and substrates for ELISA and line immunoassay (LINE) formats. These products are used to detect specific antibodies against pathogens like *Toxoplasma gondii*, adenovirus, and tick-borne encephalitis (TBE/FSME), as well as general-purpose conjugates for human IgA and IgM assays.

The company is based in Germany, specifically in Frankfurt. This location aligns with the EU regulatory framework, ensuring compliance with In Vitro Diagnostic Regulation (IVDR) requirements for their products.

The devices produced by Gold Standard Diagnostics Frankfurt GmbH are listed in the eudamed database, which is the official EU registry for in-vitro diagnostic (IVD) devices. This registry ensures transparency and traceability of IVD products under the EU In Vitro Diagnostic Regulation (IVDR).

The devices fall under EU IVD classifications, including Class A (low-risk devices) and Annex II List B (higher-risk IVDs requiring additional scrutiny). Additionally, they are categorized under the broader IVD General classification, which covers a wide range of diagnostic reagents and substrates. These classifications determine the regulatory requirements for their development, manufacturing, and market placement.