BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOGX

    Reg #: 3010749841 · FEI: 3010749841 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    BIOGX
    Registration Number
    3010749841
    FEI Number
    3010749841
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2450 Valleydale Rd
    City
    Birmingham
    State
    AL
    ZIP
    35244
    Country
    US

    Owner / Operator

    Firm Name
    BioGX
    Operator Number
    10054546
    Address
    2450 Valleydale Rd
    City
    Birmingham
    State
    AL
    Postal Code
    35244
    Country
    US
    Correspondent
    Christopher Hughes

    Products

    Device Name Product Code
    Candida Species Nucleic Acid Detection System PII
    Lower Respiratory Microbial Nucleic Acid Detection System QBH
    Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System PLO
    Mycoplasma Pneumoniae Dna Assay System OZX
    Fungal Organisms, Nucleic Acid-Based Assay PEO
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Gram-Positive Bacteria And Their Resistance Markers PAM
    Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples PGI
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Bordetella Pertussis Dna Assay System OZZ
    Group A Streptococcus Nucleic Acid Amplification Assay System OYZ
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PCH
    Source Localization Software For Electroencephalograph Or Magnetoencephalograph OLX
    Gram-Negative Bacteria And Associated Resistance Markers PEN

    Proprietary Names

    BioGX - Candida Speciation GATPK - OSR for BD MAX BioGX - Candida-Trichomonas - OSR for BD MAX BioGX - Mycobacterium tuberculosis Complex - OSR for BD MAX BioGX - Viral Meningitis HSV/VZV - OSR for BD MAX BioGX - Bacterial Meningitis ELGBS - OSR for BD MAX BioGX - Bacterial Meningitis NSH - OSR for BD MAX BioGX - Mycoplasma-Ureaplasma - OSR for BD MAX BioGX - Pneumocystis jirovecii - OSR for BD MAX BioGX - Flu A, Flu B, RSV A/B - OSR for BD MAX BioGX - Vancomycin Resistance - OSR for BD MAX BioGX - vanA/B - OSR for BD MAX BioGX - Lesion HSVHD - OSR for BD MAX BioGX - Syphilis - OSR for BD MAX BioGX - Bordetella Speciation Plus Toxin - OSR for BD MAX BioGX - Bordetella pertussis/parapertussis - OSR for BD MAX BioGX - Group A Streptococcus - OSR for BD MAX Xfree COVID-19 Direct RT-PCR BioGX - Urinary Tract EKEGAS - OSR for BD MAX BioGX - Parasitic Enteric CGED - OSR for BD MAX BioGX - EBV - OSR for BD MAX BioGX - Carbapenem Resistance KNO - OSR for BD MAX BioGX - Carbapenem/Colistin Resistance VGM - OSR for BD MAX

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device