BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MERIDIAN BIOSCIENCE, INC.

    Reg #: 1524213 · FEI: 1524213 · Expires 2026
    View on FDA
    Products
    51
    Proprietary Names
    137
    Establishment Types
    5
    Classifications
    51

    Registration Details

    Registration Name
    MERIDIAN BIOSCIENCE, INC.
    Registration Number
    1524213
    FEI Number
    1524213
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3471 River Hills Dr
    City
    Cincinnati
    State
    OH
    ZIP
    45244
    Country
    US

    Regulatory Submissions

    510(k) Number
    K792717

    Owner / Operator

    Firm Name
    MERIDIAN BIOSCIENCE, INC.
    Operator Number
    1524213
    Address
    3471 RIVER HILLS DR., --
    City
    Cincinnati
    State
    OH
    Postal Code
    45244
    Country
    US
    Correspondent
    Susan M Bogar

    Products

    Device Name Product Code
    Antiserum, Positive Control, Coccidioides Immitis GMH
    Real Time Nucleic Acid Amplification System OOI
    System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony PMY
    Formaldehyde (Formalin, Formol) IGG
    Helicobacter Pylori LYR
    Antigens, Histoplasma Capsulatum, All GMJ
    Antisera, Cf, Poliovirus 1-3 GOG
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD
    Antisera, Fluorescent, Chlamydia Spp. LKI
    Stains, Microbiologic JTS
    Campylobacter Spp. LQP
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX
    Antisera, Latex Agglutination, Cryptococcus Neoformans GMD
    Antiserum, Cf, Varicella-Zoster GQX
    Antigen, Cf And / Or Id, Coccidioides Immitis GMI
    Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples PGI
    Antigens, All Types, Escherichia Coli GMZ
    Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test NJR
    Kit, Serological, Positive Control MJX
    Antigen, Elisa, Cryptococcus MDU
    Fixative, Metallic Containing LDX
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA
    Reagents, Clostridium Difficile Toxin LLH
    Mycoplasma Pneumoniae Dna Assay System OZX
    Enzyme Linked Immunosorbent Assay, Coccidioides Immitis MIY
    Enzyme Linked Immunoabsorbent Assay, Rotavirus LIQ
    C. Difficile Toxin Gene Amplification Assay OZN
    Antisera, All Types, Escherichia Coli GNA
    Formulations, Mercuric Chloride For Tissue IFQ
    Pneumocystis Carinii LYF
    Container, Specimen Mailer And Storage, Sterile KDT
    Group A Streptococcus Nucleic Acid Amplification Assay System OYZ
    C. Difficile Nucleic Acid Amplification Test Assay OMN
    Bordetella Pertussis Dna Assay System OZZ
    Legionella, Spp., Elisa MJH
    Container, Specimen, Sterile FMH
    Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection QDZ
    Antiserum, Positive Control, Histoplasma Capsulatum GMK
    Device, Parasite Concentration LKS
    Antigen, C. Difficile MCB
    Stain, Trichrome, Mallory'S HYW
    Applicator, Absorbent Tipped, Sterile KXG
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Multi-Analyte Controls Unassayed OHQ
    System, Test, Infectious Mononucleosis KTN
    Giardia Spp. MHI
    Antigen, Latex Agglutination, Coccidioides Immitis GMG
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. LJZ
    Plates And Equipment, Radial Immunodiffusion JZQ
    Culture Media, Non-Propagating Transport JSM

    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 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 250050 MERIFLUOR Crypto/Giardia 618096 Premier CAMPY 150100 Coccidioides Latex Agglutination System 710030 ImmunoCard H. pylori 601396 Premier Platinum HpSA PLUS 760630_Curian Shiga Toxin Curian Shiga Toxin 696004 Premier Rotaclone 782030 ImmunoCard STAT! Flu A&B 781130 ImmunoCard STAT! A&B Accessory Kit Curian HpSA 610190 Curian Analyzer 760130 Curian HpSA Curian Analyzer 696006 Premier Adenoclone 40/41 410200 revogene GBS LB revogene GBS LB 709030 ImmunoCard Mycoplasma 101012 Single series plate 101009 Four series plate Para-Pak C&S 505021 Viral Transport

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198