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510(k) Data Aggregation

    K Number
    K981573
    Device Name
    UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1998-09-15

    (134 days)

    Product Code
    JFH
    Regulation Number
    862.1020
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of PAP level in human serum to aid in the management and monitoring the effectiveness of various therapeutic treatments of prostate cancer patients. (for Professional use only)
    Device Description
    The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA).
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    K Number
    K973154
    Device Name
    UBI MAGIWEL MARIJUANA METABOLITES
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1998-07-22

    (334 days)

    Product Code
    LDJ
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UBI MAGIWEL™ Marijuana metabolites is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Marijuana metabolites in human urine. (for Professional use only)
    Device Description
    solid phase enzyme-linked immunosorbent assay(ELISA)
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    K Number
    K973692
    Device Name
    UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1998-02-09

    (136 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UBI MAGIWEL™ C-Reactive Protein(CRP) AD-401 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of CRP level in human serum to aid in the evaluation of the amount of injury to body tissues. (for Professional use only)
    Device Description
    The UBI MAGIWEL™ C-Reactive Protein(CRP) AD-401 is a solid phase enzyme-linked immunosorbent assay(ELISA).
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    K Number
    K973153
    Device Name
    UBI MAGIWEL AMPHETAMINE METABOLITES
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1997-10-28

    (67 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE UBI MAGIWEL™ Amphetamine metabolites is a solid phase enzyme-linked immonosorbent assay(ELISA). This test provides a specific and sensitive assay to qualitatively detect the major amphetamine metabolites in human urine.
    Device Description
    solid phase enzyme-linked immonosorbent assay(ELISA)
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    K Number
    K973155
    Device Name
    UBI MAGIWEL OPIATE METABOLITES
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1997-10-28

    (67 days)

    Product Code
    DJG, DAT
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UBI MAGIWEL™ Opiate metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Opiate metabolites in human urine. (for Professional use only)
    Device Description
    The UBI MAGIWEL™ Opiate metabolites is a solid phase enzymelinked immunosorbent assay(ELISA).
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    K Number
    K973156
    Device Name
    UBI MAGIWEL COCAINE METABOLITES
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1997-10-28

    (67 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UBI MAGIWEL™ Cocaine metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides miked innifullosorbent of Cocaine metabolites in human urine. (for Professional use only)
    Device Description
    solid phase enzyme-linked immunosorbent assay(ELISA)
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    K Number
    K962211
    Device Name
    UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1996-07-08

    (28 days)

    Product Code
    KLI
    Regulation Number
    862.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K961236
    Device Name
    UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1996-05-30

    (62 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED BIOTECH, INC.

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

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