Medical Device Manufacturer · US , Cincinnati , OH

Meridian Bioscience, Inc.

38 submissions · 37 cleared · Since 2003
38
Total
37
Cleared
1
Denied

Meridian Bioscience, Inc. — FDA 510(k) Submissions

Meridian Bioscience, Inc. has submitted 38 FDA 510(k) premarket notifications since 2003, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Helicobacter Pylori, Devices Detecting Influenza A, B, And C Virus Antigens, Antigens, All Types, Escherichia Coli, Mycoplasma Pneumoniae Dna Assay System, Real Time Nucleic Acid Amplification System . Use the specialty filter in the sidebar to narrow results.

38 devices
1–25 of 38
Revogene
K243922 · OOI Real Time Nucleic Acid... · Microbiology
Mar 2025 90d
Premier HpSA Flex (619096)
K230901 · LYR Helicobacter Pylori · Microbiology
Jul 2023 94d
Curian? Shiga Toxin
K222829 · GMZ Antigens, All Types,... · Microbiology
Apr 2023 210d
Revogene
K222779 · OOI Real Time Nucleic Acid... · Microbiology
Jan 2023 134d
Revogene
K220480 · OOI Real Time Nucleic Acid... · Microbiology
Jul 2022 143d
Curian Campy
K210976 · LQP Campylobacter Spp. · Microbiology
Dec 2021 266d
Curian HpSA, Curian Analyzer
K192817 · LYR Helicobacter Pylori · Microbiology
Mar 2020 164d
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
DEN180040 · QDZ Qualitative... · Microbiology
Nov 2018 123d
PREMIER Platinum HpSA PLUS
K182559 · LYR Helicobacter Pylori · Microbiology
Nov 2018 49d
TRU Legionella
K163273 · MJH Legionella, Spp., Elisa · Microbiology
Feb 2017 92d
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
K160829 · OZX Mycoplasma Pneumoniae Dna... · Microbiology
Jun 2016 80d
ImmunoCard STAT! HpSA
K153661 · LYR Helicobacter Pylori · Microbiology
Mar 2016 84d
illumigene Pertussis DNA Amplification Assay
K152285 · OZZ Bordetella Pertussis Dna... · Microbiology
Nov 2015 90d
illumigene Mycoplasma DNA Amplification Assay
K152800 · OZX Mycoplasma Pneumoniae Dna... · Microbiology
Oct 2015 25d
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
K151046 · PGI Herpes Virus (vzv, Hsv1,... · Microbiology
Jul 2015 88d
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
K133673 · OZZ Bordetella Pertussis Dna... · Microbiology
Mar 2014 116d
TRU FLU
K133714 · PSZ Devices Detecting... · Microbiology
Jan 2014 29d
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
K123423 · OZX Mycoplasma Pneumoniae Dna... · Microbiology
Jun 2013 211d
STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
K122019 · OYZ Group A Streptococcus... · Microbiology
Sep 2012 65d
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
K121044 · NJR Nucleic Acid... · Microbiology
May 2012 25d
TRU LEGIONELLA
K113190 · MJH Legionella, Spp., Elisa · Microbiology
Feb 2012 116d
IMMUNOCARD C. DIFFICILE GDH
K112048 · MCB Antigen, C. Difficile · Microbiology
Dec 2011 151d
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
K112125 · NJR Nucleic Acid... · Microbiology
Dec 2011 133d
PREMIER C. DIFFICILE GDH
K110620 · MCB Antigen, C. Difficile · Microbiology
May 2011 61d
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
K110012 · OMN C. Difficile Nucleic Acid... · Microbiology
Feb 2011 52d
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