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    K Number
    K203530
    Device Name
    Albumin BCP2
    Manufacturer
    Abbott Ireland Diagnostics Division
    Date Cleared
    2022-03-18

    (471 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Why did this record match?
    Product Code :

    CJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Albumin BCP2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System. The Albumin BCP2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
    Device Description
    The Albumin BCP2 assay is an automated clinical chemistry assay. The Albumin BCP2 procedure is based on the binding of bromocresol purple specifically with human albumin to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample. Methodology: Colorimetric (Bromocresol Purple)
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    K Number
    K193001
    Device Name
    Albumin BCP
    Manufacturer
    Sentinel CH. SpA
    Date Cleared
    2019-12-19

    (52 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Why did this record match?
    Product Code :

    CJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The assay is intended for professional use only. For In Vitro Diagnostic use only.
    Device Description
    Albumin BCP reagent is ready to use liquid reagent that is supplied in two configurations: fill volume 20 mL in a 20 mL wedge or 50 mL in a 50 mL wedge, 6 wedges/kit.
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    K Number
    K132664
    Device Name
    ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Date Cleared
    2013-10-16

    (50 days)

    Product Code
    CJW, JIX
    Regulation Number
    862.1035
    Why did this record match?
    Product Code :

    CJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on ADVIA Chemistry systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. For in vitro diagnostic use in the calibration of the ADVIA Chemistry Albumin BCP Assay (ALBP) on ADVIA Chemistry systems.
    Device Description
    The Albumin BCP reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry systems. Reagents are supplied in two configurations: fill volume of 18 mL in a 20 mL wedge or 35 mL in a 40 mL wedge, 4 wedges/kit. The calibrator is a multi-analyte human serum based product containing albumin derived from human serum. The kit consists of 3 vials of one-level calibrator which are lyophilized. The target concentration of this calibrator is 4.3 g/dL. The volume per vial (after reconstitution with deionized water) is 2.0 mL.
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    K Number
    K021636
    Device Name
    ALBUMIN REAGENT
    Manufacturer
    INTERSECT SYSTEMS, INC.
    Date Cleared
    2002-07-17

    (61 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Why did this record match?
    Product Code :

    CJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An albumin test system is an in vitro device intended to measure albumin concentration quantitatively in serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
    Device Description
    Not Found
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    K Number
    K000483
    Device Name
    RANDOX ALBUMIN
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2000-03-31

    (46 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Why did this record match?
    Product Code :

    CJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990978
    Device Name
    ALBUMIN BCG, MODEL AL 103-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-05-25

    (63 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Why did this record match?
    Product Code :

    CJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE Albumin BCG reagent is intended for Invitro diagnostic in the quantitative determination of albumin in serum use or plasme.
    Device Description
    Not Found
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    K Number
    K981814
    Device Name
    ALBP
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-07-22

    (61 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Why did this record match?
    Product Code :

    CJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Albumin BCP is used for the quantitation of albumin in human serum or plasma. Albumin BCP measurements are used in the diagnosis and treatment of kidney disease and liver disease.
    Device Description
    Albumin BCP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum or plasma. The Albumin BCP assay is a clinical chemistry assay in which the albumin in the sample binds to a bromocresol purple dye in acidic media to form a colored complex. The absorbance of the albumin chromophore complex is measured at 604 nm and is directly proportional to the concentration of albumin present in the sample.
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    K Number
    K981457
    Device Name
    ALBP
    Manufacturer
    ABBOTT MFG., INC.
    Date Cleared
    1998-05-27

    (34 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Why did this record match?
    Product Code :

    CJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Albumin BCP assay is used for the quantitation of albumin in human serum. Albumin BCP measurements are used in the diagnosis and treatment of kidney disease and liver disease.
    Device Description
    Albumin BCP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum. The Albumin BCP assay is a clinical chemistry assay in which the albumin in the sample binds to bromcresol purple. The absorbance of the complex is measured at 600 nm and is directly proportional to the albumin concentration in the sample.
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