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    K Number
    K070334
    Device Name
    R&D SICKLE QC CONTROL
    Manufacturer
    R & D SYSTEMS, INC.
    Date Cleared
    2007-03-29

    (52 days)

    Product Code
    GGM
    Regulation Number
    864.8625
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.
    Device Description
    Sickle QC is a control for solubility tests used to detect Hemoglobin S. Sickle QC is compatible with other manufacturer's solubility kits. The control contains human red blood cells that are processed and are suspended in an anti-microbial solution that completes the simulation of fresh whole blood.
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    K Number
    K023656
    Device Name
    SICKLE-CHEX SOLUBILITY KIT
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2002-12-30

    (61 days)

    Product Code
    GHM
    Regulation Number
    864.7825
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sickle-Chex Solubility Kit is a qualitative solubility test kit for tasting the presence of sickling hemoglobins in human blood or sickle cell control materlal.
    Device Description
    Sickle-Chex Solubility Kit consists of: - Sickle-Chex Solubility Buffer; two LDPE bottles, each illied ville 100mL of a A. 2.3M potassium phosphate buffer solution containing Saponin. - Sickle-Chex Reagent Powder; two glass vials, each filled with 4 grams of B. Sodium Hydrosulfite. The testing principles of the kit is based on NCCLS, H10-F.
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    K Number
    K013316
    Device Name
    SICKLE-CHEX
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2001-11-06

    (33 days)

    Product Code
    GHM
    Regulation Number
    864.7825
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sickle-Chex is intended to be used as a sickle cell control in testing for the presence of hemoglobin S in solubility tests and hemoglobin electrophoresis.
    Device Description
    Sickle-Chex consists of Control materials for verifying performance of sickle cell hemoglobin testing systems. The controls contain human red blood cells and preservative suspension media packaged in a polyethylene dropper bottle with dispensing tip. Product fill is 2.5 ml per vial.
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    K Number
    K955719
    Device Name
    SICKLE-2000
    Manufacturer
    MEDICUS TECHNOLOGIES, INC.
    Date Cleared
    1996-08-14

    (240 days)

    Product Code
    GIQ
    Regulation Number
    864.7415
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SICKLE-2000 is an in-vitro centrifugal solubility test that detects Hemoglobin S, the abnormal hemoglobin found in sickle cell disease and sickle cell trait.
    Device Description
    SICKLE-2000 is an in-vitro centrifugal solubility test that detects Hemoglobin S, the abnormal hemoglobin found in sickle cell disease and sickle cell trait.
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