Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K052645
    Device Name
    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Date Cleared
    2005-12-14

    (79 days)

    Product Code
    GTQ
    Regulation Number
    866.3720
    Why did this record match?
    Product Code :

    GTQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 28 is used in coniunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin O (ASO). For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems. For in vitro diagnostic use only. VITROS Chemistry Products ASO/RF Performance Verifiers are assayed controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS Chemistry Systems.
    Device Description
    The quantitative measurement of antistreptolysin O is performed using the VITROS Chemistry Products ASO Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 28 and VITROS Chemistry Products FS Calibrator 1 on VITROS 5,1 FS Chemistry Systems. VITROS Chemistry Products Calibrator Kit 28 is an aqueous solution containing processed human serum, protein, inorganic salt, and preservative. VITROS Chemistry Products FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline). VITROS Chemistry Products ASO/RF Performance Verifiers contain two levels of lyophilized assayed controls for use in monitoring performance of VITROS ASO and RF Reagents on VITROS 5,1 FS Chemistry Systems. These controls are prepared from processed human serum to which purified human proteins, bovine serum albumin and preservative have been added. These controls are reconstituted with VITROS Chemistry Products FS Reconstitution Diluent that contains processed water.
    Ask a Question

    Page 1 of 1