Are allergens considered ASRs?
Allergens would not be considered ASRs: if more than one allergen is combined together by the manufacturer, e.g. AgA + AgB in the same vial; if more than one ASR is bundled together in a single pre-configured or optimized mixture so that they must be used together in the resulting laboratory developed test; if the product marketed includes some or all of the products needed to conduct a particular test; if they are designed or formatted to be used only on a specific instrument; if they are promoted for use with specific named reagents e.g. buffers, diluents or controls used with that instrument; or if they are marketed with analytical or clinical performance claims.
