Data / Medical devices / United States / Meridian Bioscience, Inc.
Meridian Bioscience, Inc.: FDA-registered device maker in Cincinnati, OH, United States, 59 510(k) clearances
Meridian Bioscience, Inc. is registered with the FDA (registration 1524213) in Cincinnati, OH, United States. It lists 51 device types. The FDA files 59 510(k) clearances under its listings, the newest dated March 20, 2025. 16 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1524213
- Address
- 3471 River Hills Dr, Cincinnati, OH, United States, 45244
- Owner or operator
- MERIDIAN BIOSCIENCE, INC. (1524213)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 16, 1992
- Registered through
- 2026
- Brand names listed
- 100201 Histoplasma antigen, 100401 Coccidioides F antigen, 100405 Coccidioides F antigen, 100601 Anti-Histoplasma, 100801 Anti-Coccidioides F, 101009 Four series plate, 101012 Single series plate, 103001 Coccidioides TP antigen and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 20, 2025 | K243922 | Revogene | OOI | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| October 7, 2024 | DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | SCA | Unknown | Healgen | accessdata.fda.gov |
| July 3, 2023 | K230901 | Premier HpSA Flex (619096) | LYR | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| April 17, 2023 | K222829 | Curian® Shiga Toxin | GMZ | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| January 26, 2023 | K222779 | Revogene | OOI | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| July 11, 2022 | K220480 | Revogene | OOI | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| December 23, 2021 | K210976 | Curian Campy | LQP | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| March 13, 2020 | K192817 | Curian HpSA, Curian Analyzer | LYR | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| May 10, 2019 | K190275 | GenePOC Carba | PMY | Substantially Equivalent | Genepoc, Inc. | accessdata.fda.gov |
| March 6, 2019 | K183366 | GenePOC Strep A | PGX | Substantially Equivalent | Genepoc, Inc. | accessdata.fda.gov |
| November 30, 2018 | DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | QDZ | Unknown | Meridian Bioscience, Inc. | accessdata.fda.gov |
| November 5, 2018 | K182559 | PREMIER Platinum HpSA PLUS | LYR | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| November 22, 2017 | K172569 | GenePOC CDiff | OZN | Substantially Equivalent | Genepoc, Inc. | accessdata.fda.gov |
| May 25, 2017 | K170558 | revogene | OOI | Substantially Equivalent | Genepoc, Inc. | accessdata.fda.gov |
| May 25, 2017 | K170557 | GenePOC GBS LB | NJR | Substantially Equivalent | Genepoc, Inc. | accessdata.fda.gov |
| June 13, 2016 | K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 | OZX | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| July 17, 2015 | K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 | PGI | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| March 25, 2014 | K133673 | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA | OZZ | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| June 5, 2013 | K123423 | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT | OZX | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| September 13, 2012 | K122019 | STREPTOCOCCUS APP. SEROLOGICAL REAGENTS | OYZ | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| February 24, 2012 | K113190 | TRU LEGIONELLA | MJH | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| December 16, 2011 | K112048 | IMMUNOCARD C. DIFFICILE GDH | MCB | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| December 5, 2011 | K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT | NJR | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| May 3, 2011 | K110620 | PREMIER C. DIFFICILE GDH | MCB | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| November 10, 2010 | K083746 | BIOSIGN FLU A+B | PSZ | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| July 9, 2010 | K100818 | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 | OMN | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| May 28, 2009 | K090700 | IMMUNOCARD STAT CAMPY, MODEL 751530 | LQP | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| January 30, 2009 | K083464 | PREMIER CAMPY, MODEL 618096 | LQP | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| October 18, 2007 | K071101 | TRU RSV | GOG | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| February 14, 2007 | K062546 | IMMUNOCARD STAT! EHEC, MODEL 751630 | GMZ | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| March 10, 2006 | K053335 | PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 | LYR | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| August 20, 2004 | K041003 | IMMUNOCARD TOXINS A & B, MODEL 712050 | LLH | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| December 5, 2003 | K032222 | IMMUNOCARDSTAT HPSA | LYR | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| January 3, 2003 | K023599 | IMMUNOCARD STAT! E. COLI O157 PLUS | GMZ | Substantially Equivalent | Meridian Bioscience, Inc. | accessdata.fda.gov |
| December 10, 1999 | K993914 | PREMIER TOXINS A&B, MODEL 616096 | LLH | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| August 20, 1997 | K971585 | IMMUNOCARD STAT! ROTAVIRUS | LIQ | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| January 21, 1997 | K961508 | IMMUNOCARD H. PYLORI | LYR | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| March 3, 1995 | K945558 | PREMIER(TM) H. PYLORY | LYR | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| September 20, 1994 | K934550 | IMMUNOCARD MYCOPLASMA | LJZ | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| July 10, 1992 | K915493 | PREMIER COCCIDIOIDES | MIY | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| October 16, 1990 | K904400 | MERIFLUOR TM PNEUMOCYSTIS MODIFICATION | LYF | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| September 8, 1989 | K894845 | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE | GMD | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| July 8, 1988 | K881894 | ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) | GOD | Substantially Equivalent | Cambridge Bioscience Corp. | accessdata.fda.gov |
| February 24, 1988 | K873082 | ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST | GOD | Substantially Equivalent | Cambridge Bioscience Corp. | accessdata.fda.gov |
| December 14, 1987 | K874678 | I.M.N. LATEX | KTN | Substantially Equivalent | Biokit USA, Inc. | accessdata.fda.gov |
| February 21, 1986 | K860034 | PARA-PAK MACRO-CON | LKS | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| November 5, 1985 | K852969 | ROTACLONE ROTAVIRUS DIAGNOSTIC KIT | LIQ | Substantially Equivalent | Cambridge Bioscience Corp. | accessdata.fda.gov |
| August 28, 1985 | K853500 | ORTHO VIRAL TRANSPORT | JSM | Substantially Equivalent | Ortho Diagnostic Systems, Inc. | accessdata.fda.gov |
| June 25, 1984 | K841526 | ORTHO VARICELLA-ZOSTER VIRUS IDENT. | GQX | Substantially Equivalent | Ortho Diagnostic Systems, Inc. | accessdata.fda.gov |
| May 4, 1983 | K830342 | CULUTURE SET CHLAMYDIA ISOLATION AND | LKI | Substantially Equivalent | Immulok, Inc. | accessdata.fda.gov |
| January 24, 1980 | K792699 | OUCHTERLONY AGAR PLATES | JZQ | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| January 23, 1980 | K792701 | HISTOPLASMA CAPSULATUM, ANTIGEN | GMJ | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| January 21, 1980 | K792707 | PARA-PAK SAF | IGG | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| January 21, 1980 | K792705 | PARA-PAK FORMALIN | IGG | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| January 17, 1980 | K792717 | COCCIDIOIDES IMMITIS, ANTISERUM POS. | GMH | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| January 17, 1980 | K792712 | PARA-PAK (C&S) | JSM | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| January 17, 1980 | K792684 | COCCIDIOIDES IMMITIS, ANTISERUM, | GMH | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| January 17, 1980 | K792682 | COCCIDIOIDES IMMITIS, ANTIGEN | GMI | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
| January 17, 1980 | K792679 | HISTOPLASMA CAPSULATUM, ANTISERUM | GMK | Substantially Equivalent | Meridian Diagnostics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 5, 2025 | 98038 | Class II | Ongoing | Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 | The affected lots show a decline in performance over time, which may lead to false-negative results. | accessdata.fda.gov |
| October 7, 2025 | 97787 | Class II | Ongoing | Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. | accessdata.fda.gov |
| October 19, 2023 | 93350 | Class II | Ongoing | Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312 | Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen. | accessdata.fda.gov |
| December 15, 2022 | 91356 | Class II | Ongoing | Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700 | Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2 | accessdata.fda.gov |
| June 22, 2022 | 90549 | Class II | Ongoing | Revogene, Catalog no. 610210. IVD test instrument | When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns. | accessdata.fda.gov |
| February 15, 2022 | 89666 | Class II | Ongoing | 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 | The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results. | accessdata.fda.gov |
| April 8, 2021 | 87556 | Class II | Terminated | 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 nas | Emergency Use Application (EUA) application withdrawn as false negative results reported | accessdata.fda.gov |
| February 8, 2021 | 87430 | Class II | Terminated | 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. | Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the assoc | accessdata.fda.gov |
| December 17, 2018 | 81787 | Class II | Terminated | 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 | An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control. | accessdata.fda.gov |
| November 8, 2016 | 75651 | Class II | Terminated | PREMIER EHEC and PREMIER EHEC Bulk. | Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens. | accessdata.fda.gov |
| April 22, 2014 | 68396 | Class II | Terminated | 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 reaction | Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration. | accessdata.fda.gov |
| October 10, 2011 | 60124 | Not yet classified | Terminated | 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-Substrate II 12.5ml | Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate of occurrence will likely impact clinical sensitivity as defined by product registration and associated instructions for use. | accessdata.fda.gov |
| June 2, 2006 | 35604 | Not yet classified | Terminated | 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. | The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates. | accessdata.fda.gov |
| September 23, 2003 | 27346 | Not yet classified | Terminated | Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096. | The kits were packaged with incorrect dispensing pipettes. | accessdata.fda.gov |
| June 18, 2003 | 26505 | Not yet classified | Terminated | Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G. | The Low Positive Standard kit component is losing potency that may result in false positive test results. | accessdata.fda.gov |
| December 26, 2002 | 25295 | Not yet classified | Terminated | Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box. | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. | accessdata.fda.gov |
Compare with other makers
- All makers of Antigens, Cf (Including Cf Control), Adenovirus 1-33
- All makers of Real Time Nucleic Acid Amplification System
- All makers of Mycoplasma Pneumoniae Dna Assay System
- All makers of C. Difficile Nucleic Acid Amplification Test Assay
Updated January 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.