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    Antibody test products can only be used in Laboratories certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a to perform moderate or high complexity tests.

    Antibody Test
    Antibody Test
    CareStart SARS-CoV-2 IgM/IgG Rapid Test
    FDA EUA approved
    CLIA complexity: MODERATE and HIGH
    Samples used: human serum, plasma, and venous whole blood
    10 minutes turnaround time
    Box includes: Test device, buffer bottle, blood transfer pipette, and IFU
    25 tests per box
    More...
    Antibody Test
    Antibody Test
    Lyher IgM/IgG Antibody
    FDA EUA approved
    CLIA complexity: MODERATE and HIGH
    Samples used: Plasma/Serum
    10 minutes turnaround time
    Box includes test device, specimen diluent buffer, and IFU
    40 tests per box
    More...
    Antibody Test
    Antibody Test
    Healgen IgG/IgM Rapid test
    FDA EUA approved
    CLIA complexity: MODERATE and HIGH
    Samples used: Whole Blood/Serum/Plasma
    10 minutes turnaround time
    Box includes: test device, buffer, and IFU
    25 tests per box
    More...
    Covid Antigen Test
    Covid Antigen Test
    CareStart SARS-CoV-2 Antigen Rapid Test
    FDA EUA approved
    point-of-care test with a 10 min testing time
    Sample type is direct nasopharyngeal swab specimen
    Box includes test device, extraction vial, positive and negative controls, IFU and nasopharyngeal swab.
    20 tests per box
    More...
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    CareStart Antibody EUA

    Lyher Antibody EUA

    Healgen Antibody EUA

    CareStart Antigen EUA

    Health Care Provider Face Sheet

    Recipient Fact Sheet