General laboratory reagent and consumables IVDs

Intended purpose

The Revogene®Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm that the optical and thermal parameters of the Revogene® instrument are within specifications. It is intended for use by qualified laboratory personnel who have been trained and are proficient in performing testing on the Revogene instrument, or by Meridian Bioscience, Inc. service personnel.