| Z-1019-2026 | Class II | Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Cata | December 5, 2025 |
| Z-0569-2026 | Class II | Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test A | October 7, 2025 |
| Z-0568-2026 | Class II | Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test A | October 7, 2025 |
| Z-0520-2024 | Class II | Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examinati | October 19, 2023 |
| Z-0521-2024 | Class II | Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, | October 19, 2023 |
| Z-0519-2024 | Class II | Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool speci | October 19, 2023 |
| Z-1008-2023 | Class II | Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SA | December 15, 2022 |
| Z-1479-2022 | Class II | Revogene, Catalog no. 610210. IVD test instrument | June 22, 2022 |
| Z-0836-2022 | Class II | Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. | February 15, 2022 |
| Z-1540-2021 | Class II | Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase C | April 8, 2021 |
| Z-1541-2021 | Class II | Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD | April 8, 2021 |
| Z-1299-2021 | Class II | The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: | February 8, 2021 |
| Z-0732-2019 | Class II | PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Ant | December 17, 2018 |
| Z-1033-2017 | Class II | PREMIER EHEC and PREMIER EHEC Bulk. | November 8, 2016 |
| Z-1941-2014 | Class II | illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is des | April 22, 2014 |