MERIDIAN BIOSCIENCE, INC.

FDA Device Registration & Listing · Cincinnati, OH, US · Registration 1524213

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1524213
FEI Number
1524213
Entity Name
MERIDIAN BIOSCIENCE, INC.
City/State/Country
Cincinnati, OH, US
Establishment Address
3471 River Hills Dr, Cincinnati, OH 45244, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MERIDIAN BIOSCIENCE, INC. (Owner Number: 1524213)
Owner / Operator Contact Address
3471 RIVER HILLS DR., --, Cincinnati, OH 45244, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K874678
PMA Number
N/A

All Registered Proprietary Names

Anti-Coccidiodes "TP" Control Serum 103101_Anti-Coccidiodes "TP" Control Serum 410500 revogene Carba C revogene Carba C Multiple Para-Pak configuration 901112 5% Nonbuffered Formalin Solution 606096 Premier H. pylori 100201 Histoplasma antigen 751330 TRU RSV 696007 Premier Adenoclone GSA PREMIER Platinum HpSA Plus 500111 MERIFLUOR Chlamydia 400501 Trichrome Blue TRICHROME BLUE 751530 ImmunoCard STAT! CAMPY revogene Strep A 410400 revogene Strep A 140050 CALAS Pronase 140100 CALAS 500113 MERIFLUOR VZV 100405 Coccidioides F antigen 103001 Coccidioides TP antigen 100401 Coccidioides F antigen 280650, illumigene HSV 1&2 279960, Illumigene HSV 1&2 External Control 480650 Alethia HSV 1&2 479960 Alethia HSV 1&2 External Control 750530 ImmunoCard STAT! E. coli O157 Plus 479900 Alethia Group B Streptococcus External Controls 480350 Alethia Group B Streptococcus (GBS) 279900 illumigene Group B Streptococcus External Controls 280350 illumigene Group B Streptococcus (GBS) 751110_RSV Positive Control RSV Positive Control 602096 Premier Cryptococcal Antige 750720 ImmunoCard STAT! HpSA 750220, ImmunoCard STAT! HpSA 901012 Zn-PVA 901312 EcoFix 991320 EcoFix in Biobags 401301 EcoFix Bulk 901612 Para-Pak SVT 981612 Para-Pak Ultra SVT 981312 Ultra EcoFix Multiple Para-Pak 783025 statID Pro COVID-19/Flu A&B 783010 statID Pro COVID-19/Flu A&B External Controls 616096 Premier Toxins A&B 279940, illumigene Mycoplasma External Control 280550, illumigene Mycoplasma DNA Amplification Assay 603096 Premier Coccidiodes 750030 ImmunoCard STAT! Rotavirus 410300 revogene C. difficile revogene C. difficile 608096 Premier EHEC Para-Pak LV-PVA 222030 MERIFLUOR Pneumocystis Para-Pak 900812 Enteric Plus 479910 Alethia Group A Streptococcus External Controls 480150 Alethia Group A Streptococcus 280150 illumigene Group A Streptococcus 279910 illumigene Group A Streptococcus External Control 712050 ImmunoCard Toxins A&B Multiple Para-Pak 980412 Ultra 10% Formalin 900412 10% Formalin 610210_Revogene Revogene 479920 Alethia C. difficile External Controls 480050 Alethia C. difficile 610172 illumipro-10 279920 illumigene C difficile External Controls 610189 Alethia Incubator Reader 280050 illumigene C. difficile 279890 illumigene Mycoplasma Direct External Controls 280250, illumigene Mycoplasma Direct 479890 Alethia Mycoplasma Direct External Controls 480250 Alethia Mycoplasma Direct 279930, illumigene Pertussis External Control 280750, illumigene Pertussis 479930 Alethia Pertussis External Control 480750 Alethia Pertussis 751930 TRU Legionella 900312 ParaPak Clean Vial MULTIPLE ParaPak config 990125 Direct Detect with Clean Vial 100801 Anti-Coccidioides F Alethia CMV Assay Test System 100601 Anti-Histoplasma 970120 MacroCon 619096_Premier HpSA Flex Premier HpSA Flex 990260 SAF in Tubs 900212 PAra-Pak Ultra SAF 900212 Para-Pak SAF 610210 revogene Instrument revogene Instrument 716050 ImmunoCard C. difficile GDH 610208 revogene MOCK PIE revogene MOCK PIE Curian Campy 760730_Curian Campy 801400 EcoStain 400101, 400112 Wheatly's Trichrome 801300 EcoStain StatID PRO COVID-19/Flu A&B Swab Accessory Kit revogene SARS-CoV-2 assay revogene System RNA Software Upgrade Kit 410700 revogene SARS-CoV-2 assay 610240 revogene System RNA Software Upgrade Kit 611096 Premier C. difficile GDH Revogene Check 610220_Revogene Check 751630 ImmunoCard STAT! EHEC 776150 Monospot Latex

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GMH Antiserum, Positive Control, Coccidioides Immitis Microbiology Class 2 866.3135 2007-12-03
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2020-04-07
PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony Microbiology Class 2 866.1640 2020-04-07
IGG Formaldehyde (Formalin, Formol) Pathology Class 1 864.4010 1993-11-12
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2007-12-03
GMJ Antigens, Histoplasma Capsulatum, All Microbiology Class 2 866.3320 2007-12-03
GOG Antisera, Cf, Poliovirus 1-3 Microbiology Class 1 866.3405 2007-11-30
GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33 Microbiology Class 1 866.3020 2011-10-18
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2019-04-08
LKI Antisera, Fluorescent, Chlamydia Spp. Microbiology Class 1 866.3120 2007-12-03
JTS Stains, Microbiologic Hematology Class 1 864.1850 1992-12-16
LQP Campylobacter Spp. Microbiology Class 1 866.3110 2009-06-25
PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System Microbiology Class 2 866.2680 2020-04-07
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2020-04-07
GMD Antisera, Latex Agglutination, Cryptococcus Neoformans Microbiology Class 2 866.3165 2007-12-03
GQX Antiserum, Cf, Varicella-Zoster Microbiology Class 2 866.3900 2007-12-05
GMI Antigen, Cf And / Or Id, Coccidioides Immitis Microbiology Class 2 866.3135 2007-12-03
PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples Microbiology Class 2 866.3309 2015-07-21
GMZ Antigens, All Types, Escherichia Coli Microbiology Class 1 866.3255 2011-10-18
NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Microbiology Class 1 866.3740 2011-12-15
MJX Kit, Serological, Positive Control Clinical Chemistry Class 1 862.1660 2021-04-27
MDU Antigen, Elisa, Cryptococcus Microbiology Class 2 866.3165 1993-11-12
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2007-12-03
LDX Fixative, Metallic Containing Pathology Class 1 864.4010 1992-12-16
SCA Multi-Analyte Respiratory Virus Antigen Detection Test Microbiology Class 2 866.3987 2026-04-03
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2007-12-03
OZX Mycoplasma Pneumoniae Dna Assay System Microbiology Class 2 866.3980 2013-08-11
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2013-08-11
MIY Enzyme Linked Immunosorbent Assay, Coccidioides Immitis Microbiology Class 2 866.3135 2011-10-18
LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus Microbiology Class 1 866.3405 2011-10-18
OZN C. Difficile Toxin Gene Amplification Assay Microbiology Class 2 866.3130 2020-04-07
GNA Antisera, All Types, Escherichia Coli Microbiology Class 1 866.3255 1995-05-09
IFQ Formulations, Mercuric Chloride For Tissue Pathology Class 1 864.4010 2001-08-12
LYF Pneumocystis Carinii Microbiology Class 2 866.3780 2007-12-03
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 1992-12-16
OYZ Group A Streptococcus Nucleic Acid Amplification Assay System Microbiology Class 1 866.3740 2012-11-16
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2012-11-16
LLH Reagents, Clostridium Difficile Toxin Microbiology Class 1 866.2660 2007-12-05
IGG Formaldehyde (Formalin, Formol) Pathology Class 1 864.4010 2012-11-17
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2022-11-01
OMN C. Difficile Nucleic Acid Amplification Test Assay Microbiology Class 1 866.2660 2010-12-28
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2016-06-15
OZX Mycoplasma Pneumoniae Dna Assay System Microbiology Class 2 866.3980 2016-06-15
OZZ Bordetella Pertussis Dna Assay System Microbiology Class 2 866.3980 2014-09-11
MJH Legionella, Spp., Elisa Microbiology Class 2 866.3300 2012-02-27
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2001-08-12
GMH Antiserum, Positive Control, Coccidioides Immitis Microbiology Class 2 866.3135 2011-10-18
QDZ Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection Microbiology Class 2 866.3181 2019-01-09
GMK Antiserum, Positive Control, Histoplasma Capsulatum Microbiology Class 2 866.3320 2007-12-03
LKS Device, Parasite Concentration Microbiology Class 1 866.2900 2011-10-18
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2023-09-01
IGG Formaldehyde (Formalin, Formol) Pathology Class 1 864.4010 2012-11-17
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2020-04-07
MCB Antigen, C. Difficile Microbiology Class 1 866.2660 2013-10-31
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2020-04-07
LQP Campylobacter Spp. Microbiology Class 1 866.3110 2022-02-09
HYW Stain, Trichrome, Mallory'S Hematology Class 1 864.1850 1999-11-19
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2026-05-14
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2020-11-17
MCB Antigen, C. Difficile Microbiology Class 1 866.2660 2011-10-18
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2021-01-07
GMZ Antigens, All Types, Escherichia Coli Microbiology Class 1 866.3255 2007-12-03
KTN System, Test, Infectious Mononucleosis Immunology Class 2 866.5640 2007-12-05

Official Correspondent

Susan Bogar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MERIDIAN BIOSCIENCE, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K791383 Immuno-Mycologics, Inc. CANDIDA IMMUNODIFFUSION KIT #CA1001 1979-08-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-05 Becton Dickinson & Co. 1
Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
Z-0015-2014 Sekisui Diagnostics LLC 1
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.
Z-0004-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022 Abbott Molecular, Inc. N
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1524213. Last updated year: 2026. Please use registration number 1524213 when referencing this establishment in official correspondence.
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