General microbial isolate identification control IVD
Definition
A substance containing a viable microorganism intended to be used to verify the performance of an assay or culture medium used in microbial testing for the identification of a microorganism isolated from a clinical specimen; it is not specific to any particular microbial assay. The microbial strain is typically impregnated on a suitable material (e.g., paper), air-dried and fixed onto a slide, or freeze-dried into a pellet, and may include accessories (e.g., swab, inoculating fluid).