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510(k) Data Aggregation

    K Number
    DEN100020
    Device Name
    DENV DETECT IGM CAPTURE ELISA
    Manufacturer
    INBIOS INTL., INC.
    Date Cleared
    2011-04-08

    (170 days)

    Product Code
    OSU
    Regulation Number
    866.3945
    Why did this record match?
    Applicant Name (Manufacturer) :

    INBIOS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DENV Detect IgM Capture ELISA is for the qualitative detection of IgM antibodies to DEN recombinant antigens (DENRA) in serum for the presumptive clinical laboratory diagnosis of Dengue virus infection. The assay is intended for use only in patients with clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever. Positive results must be confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease.
    Device Description
    The DENV Detect™ IgM Capture ELISA is a sandwich-type immunoassay. The test kit includes microtiter wells coated with anti-human IgM antibodies, DEN IgM Negative, and IgM Positive controls, DENV Sample Dilution Buffer, Dengue-derived recombinant antigens (DENRA) and normal cell antigens (NCA). The test kit also contains a HRPlabeled DEN-specific monoclonal antibody and tetramethylbenzidine (TMB) substrate which are used to detect DEN IgM antibodies in the wells.
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    K Number
    K041817
    Device Name
    WEST NILE DETECT IGM ELISA
    Manufacturer
    INBIOS INTL., INC.
    Date Cleared
    2004-11-19

    (136 days)

    Product Code
    NOP
    Regulation Number
    866.3940
    Why did this record match?
    Applicant Name (Manufacturer) :

    INBIOS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The West Nile Detect IgM Capture ELISA is for the qualitative detection of IgM antibodies to WNV recombinant antigens (WNRA) in serum for the presumptive clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningoencephalitis. Positive results must be confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms, or automated instruments. This assay is not FDA cleared or approved for testing blood or plasma donors.
    Device Description
    West Nile Detect IgM Capture ELISA
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    K Number
    K023483
    Device Name
    KALAZAR DETECT
    Manufacturer
    INBIOS INTL., INC.
    Date Cleared
    2003-05-06

    (201 days)

    Product Code
    LOO
    Regulation Number
    866.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    INBIOS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kalazar Detect™ Test is a rapid immuno-chromatographic strip assay for the qualitative detection of antibodies to members of L. donovani complex in human serum. This test is intended for laboratory or professional in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K001092
    Device Name
    GENERIC BLOOD GLUCOSE TEST STRIP
    Manufacturer
    INBIOS INTL., INC.
    Date Cleared
    2000-07-26

    (113 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    INBIOS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992695
    Device Name
    INSURE PRO TEST
    Manufacturer
    INBIOS INTL., INC.
    Date Cleared
    1999-10-18

    (68 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    INBIOS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insure Pro Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the detection of early pregnancy. This test is intended for laboratory or professional use only.
    Device Description
    Not Found
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    K Number
    K991515
    Device Name
    INSURE PREGNANCY TEST
    Manufacturer
    INBIOS INTL., INC.
    Date Cleared
    1999-05-28

    (28 days)

    Product Code
    DHA, JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    INBIOS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InSure Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the detection of early pregnancy. This test is intended for laboratory or professional use only.
    Device Description
    Not Found
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