9 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·January 14, 2026
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·December 20, 2023
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·December 20, 2023
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·December 20, 2023
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·April 6, 2022
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·February 1, 2023
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·November 26, 2025
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·November 26, 2025