Meridian Bioscience, Inc.
FDA 510(k) & PMA Approved Devices — 13 products
Total Devices13
Categories8
Latest Approval2025-03-20
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K243922 | Revogene | OOI | 2025-03-20 | View |
| 510(k) | K230901 | Premier HpSA Flex (619096) | LYR | 2023-07-03 | View |
| 510(k) | K222829 | Curian® Shiga Toxin | GMZ | 2023-04-17 | View |
| 510(k) | K222779 | Revogene | OOI | 2023-01-26 | View |
| 510(k) | K220480 | Revogene | OOI | 2022-07-11 | View |
| 510(k) | K210976 | Curian Campy | LQP | 2021-12-23 | View |
| 510(k) | K192817 | Curian HpSA, Curian Analyzer | LYR | 2020-03-13 | View |
| 510(k) | DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | QDZ | 2018-11-30 | View |
| 510(k) | K182559 | PREMIER Platinum HpSA PLUS | LYR | 2018-11-05 | View |
| 510(k) | K163273 | TRU Legionella | MJH | 2017-02-21 | View |
| 510(k) | K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 | OZX | 2016-06-13 | View |
| 510(k) | K153661 | ImmunoCard STAT! HpSA | LYR | 2016-03-14 | View |
| PMA | P100025 | Test, urea adult and pediatric (breath), | OZA | 2016-01-27 | View |
No matching devices.