Meridian Bioscience, Inc. - FDA 510(k) Cleared Devices

Meridian Bioscience, Inc. is a diagnostic and life science solutions company with a manufacturing facility in Cincinnati, US. The company develops integrated diagnostic products and molecular reagents for clinical and research applications.

Meridian has received 37 FDA 510(k) clearances from 38 total submissions since 2003. The company specializes exclusively in Microbiology devices, including molecular detection assays, pathogen identification systems, and diagnostic analyzers. The latest clearance in 2025 reflects continued regulatory activity and product innovation.

Recent cleared devices include the Revogene molecular system, Curian assay platforms for bacterial and parasitic detection, Premier HpSA diagnostic tests, and illumigene amplification assays. These products address gastrointestinal pathogens, sexually transmitted infections, respiratory diseases, and other infectious disease diagnostics.

Explore the full list of device names, product codes, and clearance dates in the 510(k) database.