15 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·July 9, 2014
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
PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·January 23, 2019
PREMIER EHEC and PREMIER EHEC Bulk.
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·January 25, 2017
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·May 19, 2021
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·May 19, 2021
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·March 31, 2021
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