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510(k) Data Aggregation

    K Number
    K180771
    Device Name
    Acro HCG Pregnancy Rapid Test
    Manufacturer
    Date Cleared
    2018-05-18

    (56 days)

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

    ACRO Biotech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ACRO hCG Pregnancy Rapid Test is for use by the over the counters for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is to be used in either dip mode or midstream mode for the early detection of pregnancy.
    Device Description
    The ACRO HCG Pregnancy Rapid Test is designed to be tested in midstream mode and dip mode. The ACRO HCG Pregnancy Rapid Test consists of a single test strip encased in plastic device housing, with or without an additional absorbent tip. The result is generated by immersing the tip in the urine stream for a sufficient amount of time to absorb an adequate sample volume. It is a rapid, one-step chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG.
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    K Number
    K172512
    Device Name
    ACRO HCG Pregnancy Rapid Test
    Manufacturer
    Date Cleared
    2018-02-02

    (165 days)

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

    ACRO Biotech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ACRO hCG Pregnancy Rapid Test is used by the consumer for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is used to detect the pregnancy of HCG in urine as an indication of pregnancy.
    Device Description
    The ACRO HCG Pregnancy Rapid Test is designed to be tested in midstream mode. The ACRO HCG Pregnancy Rapid Test consists of a single test strip encased in plastic device housing, with or without an additional absorbent tip. The result is generated by immersing the tip in the urine stream for a sufficient amount of time to absorb an adequate sample volume. It is a rapid, one-step chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG.
    Ask a Question

    Ask a specific question about this device

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