Company · US
Meridian Bioscience, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2025. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (0 in 12 months)
22recalls (3 in 12 months)
19recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LYR | Helicobacter Pylori | 7 |
| OOI | Real Time Nucleic Acid Amplification System | 5 |
| MCB | Antigen, C. Difficile | 4 |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 4 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 4 |
| GMZ | Antigens, All Types, Escherichia Coli | 3 |
| LLH | Reagents, Clostridium Difficile Toxin | 3 |
| LQP | Campylobacter Spp. | 3 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 3 |
| OZX | Mycoplasma Pneumoniae Dna Assay System | 3 |
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | 3 |
| FMH | Container, Specimen, Sterile | 2 |
| MJH | Legionella, Spp., Elisa | 2 |
| OZZ | Bordetella Pertussis Dna Assay System | 2 |
| GNA | Antisera, All Types, Escherichia Coli | 1 |
| GOG | Antisera, Cf, Poliovirus 1-3 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 |
| IGG | Formaldehyde (Formalin, Formol) | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 2025 | K243922 | Revogene Meridian Bioscience, Inc. | OOI |
| Jul 3, 2023 | K230901 | Premier HpSA Flex (619096) Meridian Bioscience, Inc. | LYR |
| Apr 17, 2023 | K222829 | Curian® Shiga Toxin Meridian Bioscience, Inc. | GMZ |
| Jan 26, 2023 | K222779 | Revogene Meridian Bioscience, Inc. | OOI |
| Jul 11, 2022 | K220480 | Revogene Meridian Bioscience, Inc. | OOI |
| Dec 23, 2021 | K210976 | Curian Campy Meridian Bioscience, Inc. | LQP |
| Mar 13, 2020 | K192817 | Curian HpSA, Curian Analyzer Meridian Bioscience, Inc. | LYR |
| Nov 30, 2018 | DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit Meridian Bioscience, Inc. | QDZ |
| Nov 5, 2018 | K182559 | PREMIER Platinum HpSA PLUS Meridian Bioscience, Inc. | LYR |
| Feb 21, 2017 | K163273 | TRU Legionella Meridian Bioscience, Inc. | MJH |
| Jun 13, 2016 | K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 Meridian Bioscience, Inc. | OZX |
| Mar 14, 2016 | K153661 | ImmunoCard STAT! HpSA Meridian Bioscience, Inc. | LYR |
| Nov 10, 2015 | K152285 | illumigene Pertussis DNA Amplification Assay Meridian Bioscience, Inc. | OZZ |
| Oct 23, 2015 | K152800 | illumigene Mycoplasma DNA Amplification Assay Meridian Bioscience, Inc. | OZX |
| Jul 17, 2015 | K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 Meridian Bioscience, Inc. | PGI |
| Mar 25, 2014 | K133673 | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA Meridian Bioscience, Inc. | OZZ |
| Jan 3, 2014 | K133714 | TRU FLU Meridian Bioscience, Inc. | PSZ |
| Jun 5, 2013 | K123423 | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT Meridian Bioscience, Inc. | OZX |
| Sep 13, 2012 | K122019 | STREPTOCOCCUS APP. SEROLOGICAL REAGENTS Meridian Bioscience, Inc. | OYZ |
| May 1, 2012 | K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM Meridian Bioscience, Inc. | NJR |
| Feb 24, 2012 | K113190 | TRU LEGIONELLA Meridian Bioscience, Inc. | MJH |
| Dec 16, 2011 | K112048 | IMMUNOCARD C. DIFFICILE GDH Meridian Bioscience, Inc. | MCB |
| Dec 5, 2011 | K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT Meridian Bioscience, Inc. | NJR |
| May 3, 2011 | K110620 | PREMIER C. DIFFICILE GDH Meridian Bioscience, Inc. | MCB |
| Feb 24, 2011 | K110012 | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 Meridian Bioscience, Inc. | OMN |
| Jul 9, 2010 | K100818 | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 Meridian Bioscience, Inc. | OMN |
| Sep 11, 2009 | K092553 | TRU FLU, MODEL 751230 Meridian Bioscience, Inc. | PSZ |
| May 28, 2009 | K090700 | IMMUNOCARD STAT CAMPY, MODEL 751530 Meridian Bioscience, Inc. | LQP |
| Jan 30, 2009 | K083464 | PREMIER CAMPY, MODEL 618096 Meridian Bioscience, Inc. | LQP |
| Nov 15, 2007 | K071657 | TRU FLU Meridian Bioscience, Inc. | PSZ |
| Oct 18, 2007 | K071101 | TRU RSV Meridian Bioscience, Inc. | GOG |
| Feb 14, 2007 | K062546 | IMMUNOCARD STAT! EHEC, MODEL 751630 Meridian Bioscience, Inc. | GMZ |
| Mar 10, 2006 | K053335 | PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 Meridian Bioscience, Inc. | LYR |
| Mar 16, 2005 | K041626 | IMMUNOCARD STAT! FLU A & B Meridian Bioscience, Inc. | PSZ |
| Aug 20, 2004 | K041003 | IMMUNOCARD TOXINS A & B, MODEL 712050 Meridian Bioscience, Inc. | LLH |
| Aug 13, 2004 | K041445 | IMMUNOCARD STAT! RSV MODEL #750630 Meridian Bioscience, Inc. | GQG |
| Dec 5, 2003 | K032222 | IMMUNOCARDSTAT HPSA Meridian Bioscience, Inc. | LYR |
| Jan 3, 2003 | K023599 | IMMUNOCARD STAT! E. COLI O157 PLUS Meridian Bioscience, Inc. | GMZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2026 | Meridian Bioscience Inc Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 Open, Classified |
OZN | K172569 |
| Nov 19, 2025 | Meridian Bioscience Inc Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay Open, Classified |
NJR | K121044 |
| Nov 19, 2025 | Meridian Bioscience Inc Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay Open, Classified |
OMN | K110012 |
| Dec 8, 2023 | Meridian Bioscience Inc Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites
Catalog Number: CHB900312 Open, Classified |
FMH | K792710 |
| Dec 8, 2023 | Meridian Bioscience Inc Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites
Catalog Number: 301012 Open, Classified |
IGG | K792705 |
| Dec 8, 2023 | Meridian Bioscience Inc Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites
Catalog Number: 900312 Open, Classified |
FMH | K792710 |
| Jan 20, 2023 | Meridian Bioscience Inc Revogene SARS-CoV-2_IVD real-time RT-PCR test
intended for the qualitative detection of RNA from SARSCoV-2
Catalog Number: 410700 Open, Classified |
QJR | None listed |
| Jun 22, 2022 | Meridian Bioscience Inc Revogene, Catalog no. 610210. IVD test instrument Open, Classified |
OOI | K170558 |
| Feb 15, 2022 | Meridian Bioscience Inc 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 Open, Classified |
OOI | K170558 |
| Apr 8, 2021 | Meridian Bioscience Inc 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 Prot Terminated |
QJR | None listed |
| Apr 8, 2021 | Meridian Bioscience Inc 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 Terminated |
QJR | None listed |
| Feb 8, 2021 | Meridian Bioscience Inc 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. Terminated |
LJZ | K934550 |
| Dec 17, 2018 | Meridian Bioscience Inc 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 ca Terminated |
MDU | K904393 |
| Jan 17, 2017 | Meridian Bioscience Inc PREMIER EHEC and PREMIER EHEC Bulk. Terminated |
GNA | K953362 |
| Jun 27, 2014 | Meridian Bioscience Inc 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 re Terminated |
OMN | K110012 |
| Nov 17, 2011 | Meridian Bioscience Inc EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4- Terminated |
LFX | K953362 |
| Jul 4, 2006 | Meridian Bioscience Inc ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic. Terminated |
LLH | K041003 |
| Oct 24, 2003 | Meridian Bioscience Inc Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096. Terminated |
LLH | K993914 |
| Aug 12, 2003 | Meridian Bioscience Inc Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G. Terminated |
LFZ | K924096 |
| Jan 23, 2003 | Meridian Bioscience Inc Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box. Terminated |
LYR | K983255 |
| Jan 23, 2003 | Meridian Bioscience Inc Premier brand Toxins A & B, diagnostic test kits, one kit per pouch, one pouch per shipping box. Terminated |
MCB | K993914 |
| Jan 23, 2003 | Meridian Bioscience Inc Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box. Terminated |
MCB | K926442 |