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510(k) Data Aggregation

    K Number
    K203246
    Device Name
    Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
    Date Cleared
    2021-08-04

    (273 days)

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

    Atlas Link Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Atlas One Step hCG Urine Pregnancy Test (Strip) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use. Atlas One Step hCG Urine Pregnancy Test (Cassette) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use. Atlas One Step hCG Urine Pregnancy Test (Midstream) is a visually-read, lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the early detection of pregnancy. The device is designed for over-the-counter use only. Additional clinical examination should be performed to confirm the pregnancy. The device is single use.
    Device Description
    Atlas Link Technology Co., Ltd.'s One Step hCG Urine Pregnancy Test will be sold in three formats: Strip, Cassette, and Midstream. Each format of the device contains mouse monoclonal anti-beta-hCG antibody colloidal gold conjugate pre-dried on a pad. Mouse monoclonal antialpha-hCG antibodies (on test region) and goat anti-mouse IgG (on control region) are coated and immobilized on a membrane.
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