# Meridian Bioscience, Inc.

- Location (FDA's records): Cincinnati, OH
- FDA decisions: 39 (2003–2025): 37 510(k) clearances, 1 De Novo grant and 1 original PMA approval
- Product codes: LYR (6), PSZ (4), OOI (3), LQP (3), GMZ (3), OZX (3), OMN (2), NJR (2), MCB (2), MJH (2), OZZ (2), GQG (1)
- Predicates its devices cite: 42 (11 its own); citations of its devices by later devices: 31 (11 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Binax, Inc.: 5 (https://510kreport.com/company/binax)
- Meridian Diagnostics, Inc.: 4 (https://510kreport.com/company/meridian-diagnostics)
- Idaho Technology, Inc.: 4 (https://510kreport.com/company/idaho-technology)
- Techlab, Inc.: 3 (https://510kreport.com/company/techlab)
- Cepheid: 2 (https://510kreport.com/company/cepheid)
- Thermo Biostar, Inc.: 2 (https://510kreport.com/company/thermo-biostar)
- Alexon - Trend, Inc.: 2 (https://510kreport.com/company/alexon-trend)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Firms that cite its devices most
- Techlab, Inc.: 6 (https://510kreport.com/company/techlab)
- Luminex Corporation: 2 (https://510kreport.com/company/luminex)
- Quidel Corp.: 2 (https://510kreport.com/company/quidel)
- Techlab Inc., Corporate Research Center: 2 (https://510kreport.com/company/techlab-corporate-research-center)
- First Light Diagnostics, Inc.: 1 (https://510kreport.com/company/first-light-diagnostics)
- Biomerica, Inc.: 1 (https://510kreport.com/company/biomerica)
- Great Basin Corporation: 1 (https://510kreport.com/company/great-basin)
- Diasorin Molecular, LLC: 1 (https://510kreport.com/company/diasorin-molecular)

## Its most-cited devices
- K112125: Illumigene Group B Streptococcus ,External Control Kit (2011), cited by 3
- K182559: PREMIER Platinum HpSA PLUS (2018), cited by 3
- K041003: Immunocard Toxins a & B, Model 712050 (2004), cited by 3
- K133673: Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma (2014), cited by 3
- K053335: Premier Platinum Hpsa Plus, Models 601396, 601480 (2006), cited by 3
- K062546: Immunocard Stat! Ehec, Model 751630 (2007), cited by 2

## Recent decisions
- K243922: Revogene (Mar 20, 2025)
- K230901: Premier HpSA Flex (619096) (Jul 3, 2023)
- K222829: Curian® Shiga Toxin (Apr 17, 2023)
- K222779: Revogene (Jan 26, 2023)
- K220480: Revogene (Jul 11, 2022)
- K210976: Curian Campy (Dec 23, 2021)
- K192817: Curian HpSA, Curian Analyzer (Mar 13, 2020)
- DEN180040: Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (Nov 30, 2018)

Source page: https://510kreport.com/company/meridian-bioscience