BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INBIOS INTERNATIONAL, INC.

    Reg #: 3032562 · FEI: 3002606748 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    29
    Establishment Types
    3
    Classifications
    16

    Registration Details

    Registration Name
    INBIOS INTERNATIONAL, INC.
    Registration Number
    3032562
    FEI Number
    3002606748
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    307 Westlake Ave North, Suite 300
    City
    Seattle
    State
    WA
    ZIP
    98109
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181473

    Owner / Operator

    Firm Name
    INBIOS INTERNATIONAL, INC.
    Operator Number
    9032122
    Address
    307 Westlake Ave North, Suite 300
    City
    Seattle
    State
    WA
    Postal Code
    98109
    Country
    US
    Correspondent
    ESTELA I RAYCHAUDHURI

    Products

    Device Name Product Code
    Dengue Virus Antigen Assay QCU
    Dengue Serological Reagents OSU
    Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings QVF
    Reagent, Leishmanii Serological LOO
    Coronavirus Antigen Detection Test System. QKP
    Zika Virus Serological Reagents QFO
    Elisa, Trichinella Spiralis MDT
    Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples QUU
    Over-The-Counter Covid-19 Antigen Test QYT
    Leishmania Spp. Antigen Detection Assay PIT
    Elisa, Antibody, West Nile Virus NOP
    Reagent, Coronavirus Serological QKO
    Enzyme Linked Immunosorbent Assay, T. Cruzi MIU
    Reagents, Specific, Analyte MVU
    Reagent, Rickettsia Serological LSQ
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR

    Proprietary Names

    DENV Detect NS1 ELISA DENV Detect IgM Capture ELISA SCoV-2 Ag Detect™ Rapid Test Kalazar Detect Rapid Test SCoV-2 Ag Detect™ Rapid Self-Test ZIKV Detect 2 IgM Capture ELISA Strongy DetectTM IgG ELISA Active Anthrax Detect™ Plus Rapid Test COVID-19 Detect™ Rapid Self -Test CL Detect Rapid Test Dengue Rapid Test for NS1 DENV Detect IgG ELISA West Nile Detect IgM Capture ELISA SCoV-2 Detect™ IgM ELISA SCoV-2 Detect™ IgG ELISA West Nile Dectect Capture ELISA for IgG Chagas Detect Rapid Test for T. Cruzi 1:100 Diluted 6B6C-1/HRP Conjugate Chikungunya Antigen for IgG Ready to Use Enzyme Conjugate-HRP for West Nile IgM Undiluted 6B6C-1/HRP Conjugate ITC 8.2 Purified Antigen mAb P.vivax LDH C710 solution RTU NCA for Dengue IgM RTU Dengue Antigen for IgM (DENRA) Chagas Detect Plus Rapid Test Scrub Typhus Detect for IgM/IgG Smart Detect™ SARS-CoV-2 rRT-PCR

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only