Beta-haemolytic Streptococcus serological grouping IVD, reagent

This category includes reagents used to identify the serological group of beta-haemolytic streptococci after they have been isolated and cultured from a clinical specimen. These reagents are designed to detect specific carbohydrate antigens on the bacterial cell wall, allowing classification into Lancefield groups such as A, B, C, D, F, or G, which aids in diagnosing infections like strep throat or sepsis.

As in vitro diagnostic (IVD) reagents, these products are intended for use only in conjunction with a parent IVD assay system and are not standalone tests. They are regulated as components of IVD devices and must be supplied according to the intended use of the parent test, with performance characteristics evaluated as part of the overall assay.