Chromogenic/colorimetric substrate reagent IVD

Chromogenic/colorimetric substrate reagents for in vitro diagnostics (IVDs) are chemical compounds that change color when they react with enzymes or antigens in a clinical sample. These reagents are primarily used in enzyme-linked immunoassays (ELISAs) and immunoblotting to visually detect and measure substances like hormones, proteins, or pathogens in blood, serum, or tissue samples.

These reagents are typically supplied as part of larger diagnostic kits and are regulated as IVDs, often requiring compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are not standalone devices but are essential components in laboratory testing workflows, ensuring accurate and reliable results for clinical decision-making.