FDA.reportPublic FDA data

MERIDIAN BIOSCIENCE, INC.

Matched from indexed company URL: Meridian Bioscience, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15242131524213MERIDIAN BIOSCIENCE, INC.1N2026-01-013471 River Hills Dr Cincinnati OH US 45244
30057724183005772418Meridian Bioscience Israel Ltd.1N2026-01-014 HaMaayan St Modiin Central IL 7177872

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00840733101014ANA Screen ELISA Test Kit - The Antinuclear Antibody Screening Test is a qualitative enzyme immunassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA) histones, SS-A/Ro, SS-B/La, Sm, SmRNP, Sci-70, Jo-1, and centrometric antigens, along with sera postive for immunoflourescent (IFA) HEp-2 ANAs.513-271-3700info@meridianbioscience.com
00840733101557statID Pro COVID-19/Flu External Controls - The External Control - statID Pro COVID-19/Flu A&B is ready to use external control kit for use with the statID Pro COVID-19/Flu A&B. This kit is designed to verify propr test procedure and performance of the statID Pro-COVID-19/Flu A&B.800-343-3858MBI-TechService@meridianbioscience.com
00840733101564statID Pro COVID-19/Flu A&B - The statID Pro COVID-19/Flu A&B is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.800-343-3858MBI-TechService@meridianbioscience.com
00840733101595StatID PRO COVID/Flu A&B Swabs - These dry swabs are identical in design and function to those included in the statID Pro assay kit (783025) and are being made available separately to support customer workflow needs.800-343-3858MBI-TechService@meridianbioscience.com
00840733101717PREMIER CAMPY - Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. Premier CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.513-271-3700info@meridianbioscience.com
00840733102585Hemo-De - Clearing agent for parasitology, Use as a xylene replacement in Trichrome Stain procedure, Ethyl acetate replacement in concentration procedures, Bulk reagent used in EcoStain kit.513-271-3700info@meridianbioscience.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
318481814122770K993914PREMIER TOXINS A&B, MODEL 616096LLH1999-12-10
318481604952061K980077PARA-PAK SPINCONLKS1998-04-02
318481152878923K971585IMMUNOCARD STAT! ROTAVIRUSLIQ1997-08-20
318481427555908K961508IMMUNOCARD H. PYLORILYR1997-01-21
318481750622473K945558PREMIER(TM) H. PYLORYLYR1995-03-03
318482053630730K934550IMMUNOCARD MYCOPLASMALJZ1994-09-20
318481353906021K915493PREMIER COCCIDIOIDESMIY1992-07-10
318481870412632K904400MERIFLUOR TM PNEUMOCYSTIS MODIFICATIONLYF1990-10-16
318481181140491K894845(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASEGMD1989-09-08
318481435056342K881894ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)GOD1988-07-08
318481231639166K880043EBV-NA TESTLLM1988-03-24
318481719953656K875254GULLSORB IGG INACTIVATION REAGENTDEW1988-02-17
318481976273181K874678I.M.N. LATEXKTN1987-12-14
318481184685868K873082ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TESTGOD1988-02-24
318481917035538K872617EBV-EA TESTLSE1988-01-05
318481754122477K872541ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.LJN1988-05-13
318481904622634K860034PARA-PAK MACRO-CONLKS1986-02-21
318481668987874K853500ORTHO VIRAL TRANSPORTJSM1985-08-28
318481011037537K852969ROTACLONE ROTAVIRUS DIAGNOSTIC KITLIQ1985-11-05
318481791184744K841526ORTHO VARICELLA-ZOSTER VIRUS IDENT.GQX1984-06-25
318481015787854K830342CULUTURE SET CHLAMYDIA ISOLATION ANDLKI1983-05-04
318481735936739K822734EBV IGM TESTJRY1982-12-09
318481946102476K792717COCCIDIOIDES IMMITIS, ANTISERUM POS.GMH1980-01-17
318481400742512K792712PARA-PAK (C&S)JSM1980-01-17
318481567487493K792707PARA-PAK SAFIGG1980-01-21
318481190915586K792705PARA-PAK FORMALINIGG1980-01-21
318482021466798K792701HISTOPLASMA CAPSULATUM, ANTIGENGMJ1980-01-23
318482049652248K792699OUCHTERLONY AGAR PLATESJZQ1980-01-24
318481512914534K792690COCCIDIOIDES IMMITIS, LATEX AGGLUTIGMG1980-01-17
318481936032037K792684COCCIDIOIDES IMMITIS, ANTISERUM,GMH1980-01-17
318481953491947K792682COCCIDIOIDES IMMITIS, ANTIGENGMI1980-01-17
318481487733349K792679HISTOPLASMA CAPSULATUM, ANTISERUMGMK1980-01-17
318481288423633K771062EBV TESTGNP1977-07-14
318481469894095K243922RevogeneOOI2025-03-20
318481485009041K230901Premier HpSA Flex (619096)LYR2023-07-03
669161286263714K223185BreathID® Smart SystemMSQ2022-11-10
318481566734951K222829Curian® Shiga ToxinGMZ2023-04-17
318481695859366K222779RevogeneOOI2023-01-26
669161550499612K221896BreathID Hp SystemMSQ2022-12-19
669161072565205K220494BreathID Hp Lab System, BreathID Smart SystemMSQ2022-06-23
318481373573050K220480RevogeneOOI2022-07-11
318481907741585K210976Curian CampyLQP2021-12-23
669161848117867K193610BreathID Smart SystemMSQ2020-02-06
318481688569275K192817Curian HpSA, Curian AnalyzerLYR2020-03-13
318481082383221K190275GenePOC CarbaPMY2019-05-10
318481921543081K183366GenePOC Strep APGX2019-03-06
318481675859006K182559PREMIER Platinum HpSA PLUSLYR2018-11-05
669161227449402K173777BreathID Hp Lab SystemMSQ2018-03-08
669161700466300K173772BreathID Hp SystemMSQ2018-03-08
318481225502763K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSR2017-12-10
318481354958816K172569GenePOC CDiffOZN2017-11-22
318482063784664K170558revogeneOOI2017-05-25
318481129658415K170557GenePOC GBS LBNJR2017-05-25
669161407031780K162150BreathID Hp Lab SystemMSQ2016-10-31
318481656931636K161513Anti-Borrelia burgdorferi US Westernblot (IgG)LSR2016-08-25
318481047195077K160829illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10OZX2016-06-13
318481282234062K151046illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10PGI2015-07-17
318481165691089K142038EUROIMMUN LYME ELISA(IgG/IgM)LSR2015-05-04
318482017615891K133673ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMAOZZ2014-03-25
669161715184230K130524BREATHID HP SYSTEMMSQ2013-05-22
318481966448771K123423ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KITOZX2013-06-05
318481999513615K122019STREPTOCOCCUS APP. SEROLOGICAL REAGENTSOYZ2012-09-13
318481111446164K113190TRU LEGIONELLAMJH2012-02-24
318481226685799K112125ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KITNJR2011-12-05
318481733833919K112048IMMUNOCARD C. DIFFICILE GDHMCB2011-12-16
318481620216370K110620PREMIER C. DIFFICILE GDHMCB2011-05-03
318481002814094K100818ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920OMN2010-07-09
318481161628819K090700IMMUNOCARD STAT CAMPY, MODEL 751530LQP2009-05-28
318481533240949K083746BIOSIGN FLU A+BPSZ2010-11-10
318482046916356K083464PREMIER CAMPY, MODEL 618096LQP2009-01-30
318481051302240K071101TRU RSVGOG2007-10-18
318481716018358K062546IMMUNOCARD STAT! EHEC, MODEL 751630GMZ2007-02-14
318481590345624K053335PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480LYR2006-03-10
318481612997666K041003IMMUNOCARD TOXINS A & B, MODEL 712050LLH2004-08-20
318481562637729K032222IMMUNOCARDSTAT HPSALYR2003-12-05
318481603414719K023599IMMUNOCARD STAT! E. COLI O157 PLUSGMZ2003-01-03
669162035353983K011668VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORIMSQ2001-07-09
318481753027367DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen TestSCA2024-10-07
318481332331584DEN180040Alethia CMV DNA Amplification Assay, Alethia CMV External Control KitQDZ2018-11-30
318481051080090
318481284335006
318481413357553
318481661788985
318481680187405
318481834367708
318481923999387
318481965374818
318482041478531
318481014589512
318481082659702
318481199301943
318481378694547
318481460779982
318481508750150
318481607083793
318481617439916
318481618163737
318481646634458
318481755713169
318481766583889
318481774239702
318481888156955
318481888642035

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MSQ102022-12-19
LYR82023-07-03
OOI42025-03-20
GMZ32023-04-17
LQP32021-12-23
LSR32017-12-10
JSM31985-08-28
NJR22017-05-25
OZX22016-06-13
MCB22011-12-16
LLH22004-08-20
LKS21998-04-02
LIQ21997-08-20
GOD21988-07-08
IGG21980-01-21
GMH21980-01-17
SCA12024-10-07
PMY12019-05-10
PGX12019-03-06
QDZ12018-11-30
OZN12017-11-22
PGI12015-07-17
OZZ12014-03-25
OYZ12012-09-13
MJH12012-02-24
PSZ12010-11-10
OMN12010-07-09
GOG12007-10-18
LJZ11994-09-20
MIY11992-07-10
LYF11990-10-16
GMD11989-09-08
LJN11988-05-13
LLM11988-03-24
DEW11988-02-17
LSE11988-01-05
KTN11987-12-14
GQX11984-06-25
LKI11983-05-04
JRY11982-12-09

NDC#

IDkit HP ONE

Meridian Bioscience Israel Ltd

citric acid anhydrous and 13C urea

PMN#

Revogene

2023-01-26

Meridian Bioscience, Inc.

Revogene

2022-07-11

Meridian Bioscience, Inc.

TRU FLU

2014-01-03

MERIDIAN BIOSCIENCE, INC.

TRU FLU

2007-11-15

MERIDIAN BIOSCIENCE, INC.

TRU RSV

2007-10-18

MERIDIAN BIOSCIENCE, INC.

GUDID#

statID Pro COVID-19/Flu A&B - The statID Pro COVID-19/Flu A&B is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

MERIDIAN BIOSCIENCE, INC.

2026-04-10

PREMIER CAMPY - Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. Premier CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.

MERIDIAN BIOSCIENCE, INC.

2020-09-01

ANA Screen ELISA Test Kit - The Antinuclear Antibody Screening Test is a qualitative enzyme immunassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA) histones, SS-A/Ro, SS-B/La, Sm, SmRNP, Sci-70, Jo-1, and centrometric antigens, along with sera postive for immunoflourescent (IFA) HEp-2 ANAs.

MERIDIAN BIOSCIENCE, INC.

2016-09-23

Revogene - The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.

MERIDIAN BIOSCIENCE, INC.

2020-07-15

MERIFLUOR EBV-EA IgG IFA - The MERIFLUOR EBV-EA IgG IFA Test is a sensitive and rapid immunofluorescence method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human serum. When performed according to instructions, the MERIFLUOR EBV-EA IgG IFA Test detects IgG antibodies to the diffuse (D) and restricted (R) components of the EBV-EA complex. It is of value in providing supportive information for the diagnosis of EBV associated disease.

MERIDIAN BIOSCIENCE, INC.

2020-12-09

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