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510(k) Data Aggregation

    K Number
    K050576
    Device Name
    MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H
    Manufacturer
    GOOD BIOTECH CORP.
    Date Cleared
    2005-04-21

    (45 days)

    Product Code
    DDZ, JIT, JJX
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DDZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Good Biotech Corp. (GBC) Microalbumin TIA system is intended to be used for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). Measurement of albumin aids in the diagnosis of kidney disease. GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples. GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis. For In Vitro Diagnostic Use.
    Device Description
    Good Biotech Corp. Microalbumin TIA is a ready to use reagent for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). When microalbumin of the urine sample encounters with duck anti-albumin antibody, the agglutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 340 nm is proportional to the albumin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual microalbumin concentration of the urine sample is determined by interpolation of the calibration curve obtained by standard samples with known albumin concentrations.
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    K Number
    K023860
    Device Name
    MICROALBUMIN REAGENT SET AND CALIBRATORS
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    2003-04-28

    (159 days)

    Product Code
    DDZ
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DDZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of low level albumin in human Urine. It is intended for in vitro diagnostic use only. Microalbumin has been reported in several studies to predict development of diabetic nephropathy and its mortality risk. Measurement of urine albumin is a useful indicator of early glomerular disease.
    Device Description
    Not Found
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    K Number
    K002674
    Device Name
    RANDOX MICROALBUMIN
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2000-10-05

    (38 days)

    Product Code
    DDZ
    Regulation Number
    866.5040
    Why did this record match?
    Product Code :

    DDZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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