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Meridian Bioscience, Inc.

38 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Revogene (K243922)Meridian Bioscience, Inc.2025-03-20
Premier HpSA Flex (619096) (K230901)Meridian Bioscience, Inc.2023-07-03
Curian® Shiga Toxin (K222829)Meridian Bioscience, Inc.2023-04-17
Revogene (K222779)Meridian Bioscience, Inc.2023-01-26
Revogene (K220480)Meridian Bioscience, Inc.2022-07-11
Curian Campy (K210976)Meridian Bioscience, Inc.2021-12-23
Curian HpSA, Curian Analyzer (K192817)Meridian Bioscience, Inc.2020-03-13
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (DEN180040)Meridian Bioscience, Inc.2018-11-30
PREMIER Platinum HpSA PLUS (K182559)Meridian Bioscience, Inc.2018-11-05
TRU Legionella (K163273)Meridian Bioscience, Inc.2017-02-21
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 (K160829)Meridian Bioscience, Inc.2016-06-13
ImmunoCard STAT! HpSA (K153661)Meridian Bioscience, Inc.2016-03-14
illumigene Pertussis DNA Amplification Assay (K152285)Meridian Bioscience, Inc.2015-11-10
illumigene Mycoplasma DNA Amplification Assay (K152800)Meridian Bioscience, Inc.2015-10-23
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 (K151046)Meridian Bioscience, Inc.2015-07-17
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA (K133673)Meridian Bioscience, Inc.2014-03-25
TRU FLU (K133714)Meridian Bioscience, Inc.2014-01-03
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT (K123423)Meridian Bioscience, Inc.2013-06-05
STREPTOCOCCUS APP. SEROLOGICAL REAGENTS (K122019)Meridian Bioscience, Inc.2012-09-13
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM (K121044)Meridian Bioscience, Inc.2012-05-01
TRU LEGIONELLA (K113190)Meridian Bioscience, Inc.2012-02-24
IMMUNOCARD C. DIFFICILE GDH (K112048)Meridian Bioscience, Inc.2011-12-16
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT (K112125)Meridian Bioscience, Inc.2011-12-05
PREMIER C. DIFFICILE GDH (K110620)Meridian Bioscience, Inc.2011-05-03
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (K110012)Meridian Bioscience, Inc.2011-02-24
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 (K100818)Meridian Bioscience, Inc.2010-07-09
TRU FLU, MODEL 751230 (K092553)Meridian Bioscience, Inc.2009-09-11
IMMUNOCARD STAT CAMPY, MODEL 751530 (K090700)Meridian Bioscience, Inc.2009-05-28
PREMIER CAMPY, MODEL 618096 (K083464)Meridian Bioscience, Inc.2009-01-30
TRU FLU (K071657)Meridian Bioscience, Inc.2007-11-15
TRU RSV (K071101)Meridian Bioscience, Inc.2007-10-18
IMMUNOCARD STAT! EHEC, MODEL 751630 (K062546)Meridian Bioscience, Inc.2007-02-14
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 (K053335)Meridian Bioscience, Inc.2006-03-10
IMMUNOCARD STAT! FLU A & B (K041626)Meridian Bioscience, Inc.2005-03-16
IMMUNOCARD TOXINS A & B, MODEL 712050 (K041003)Meridian Bioscience, Inc.2004-08-20
IMMUNOCARD STAT! RSV MODEL #750630 (K041445)Meridian Bioscience, Inc.2004-08-13
IMMUNOCARDSTAT HPSA (K032222)Meridian Bioscience, Inc.2003-12-05
IMMUNOCARD STAT! E. COLI O157 PLUS (K023599)Meridian Bioscience, Inc.2003-01-03

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