Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K121122
    Device Name
    DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
    Manufacturer
    BIOCHEMICAL DIAGNOSTIC, INC.
    Date Cleared
    2012-07-03

    (81 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHEMICAL DIAGNOSTIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Detectabuse® Liquid control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
    Device Description
    Not Found
    Ask a Question
    K Number
    K050328
    Device Name
    PREGNANCY-SKREEN
    Manufacturer
    BIOCHEMICAL DIAGNOSTIC, INC.
    Date Cleared
    2005-03-29

    (48 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCHEMICAL DIAGNOSTIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pregnancy-Skreen™ controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices. The Biochemical Diagnostics, Inc., Pregnancy-Skreen™ urine controls are intended to validate the performance of qualitative hCG methods. They should be used as an external quality control to monitor the performance of the "specimen while following the specific protocol of the assay being used. This product is intended to be used by health care professionals as an integral part of good laboratory practices.
    Device Description
    These products are manufactured in a liquid matrix solution prepared with negative human urine, chemicals, and preservatives. The matrix is not known to interfere with any immunoassay procedures including those used in handheld devices. The positive control is spiked in a target range of 200-400 mIU of Human Chorionic Gonadotropin per mL of urine.
    Ask a Question

    Page 1 of 1