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    K Number
    K090753
    Device Name
    THERATEST EL-ANTI-CCP/2
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2010-03-05

    (350 days)

    Product Code
    NHX
    Regulation Number
    866.5775
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATEST LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TheraTest EL-anti-CCP/2™ test is intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum by enzyme-linked immunosorbent assay (ELISA). It is intended to aid in the diagnosis of Rheumatoid arthritis (RA) in conjunction with other clinical findings and laboratory tests.
    Device Description
    Not Found
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    K Number
    K090760
    Device Name
    THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2009-09-03

    (164 days)

    Product Code
    JZO
    Regulation Number
    866.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATEST LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TheraTest EL-Anti-TPO™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroid peroxidase (TPO) in human serum. The TheraTest EL-Anti-TPO™ assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings. The TheraTest EL-Anti-Thyroglobulin™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroglobulin in human serum. The TheraTest EL-Anti-ThyroglobulinTM assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings.
    Device Description
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    K Number
    K071692
    Device Name
    THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2007-11-05

    (138 days)

    Product Code
    MVM, MST
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATEST LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TheraTest EL-tTG™ IgA/IgG and TheraTest EL-GLIATM IgA/IgG Kits are enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum. Detection and semi-quantitation of these antibodies is intended to aid the diagnosis of patients with gluten sensitive enteropathies: celiac disease and dermatitis herpetiformis, in conjunction with other clinical findings and laboratory tests.
    Device Description
    enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum.
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    K Number
    K061376
    Device Name
    EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2006-07-20

    (64 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATEST LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TheraTest EL- ANCATM: anti-MPO- and EL- ANCA™: anti-PR3 are intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase and proteinase 3, respectively. Measurement of anti-MPO aids in the diagnosis of microscopic polyangiitis. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis.
    Device Description
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    K Number
    K060176
    Device Name
    EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2006-02-07

    (15 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATEST LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TheraTest EL-aCL™screen and TheraTest EL-aCL™ IgM, InG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin.
    Device Description
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    K Number
    K051066
    Device Name
    THERATEST EL-ANA PROFILES
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2005-10-07

    (164 days)

    Product Code
    LKP, LJM, LKO, LLL, LRM, MQA
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATEST LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EL-ANA Profiles™ is an in vitro diagnostic test for the detection and measurement of autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), Smith, RNP/Sm, SSA (Ro) "R, SSB (La) "R (30217), Gould Carding Ribosomal Protein P, Centromere™, and Chromatin (Nucleosomes). This test system is intended as an aid in diagnosis of systemic lupus erythematosus, Sjogren's syndrome, progressive systemic sclerosis (scleroderma), drug-induced lupus and polymyositis.
    Device Description
    Not Found
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    K Number
    K040291
    Device Name
    EL-ANA PROFILES: ANTI-CHROMATIN
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2004-03-11

    (34 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATEST LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To aid in the diagnosis of systemic lupus erythematosus and related conditions.
    Device Description
    Not Found
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    K Number
    K024031
    Device Name
    THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2003-02-06

    (62 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATEST LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EL-ANA Profiles™ is intended to measure autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), doublestranded DNA (dsDNA), Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P, and Centromere. This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases.
    Device Description
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    K Number
    K024151
    Device Name
    EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2003-02-06

    (62 days)

    Product Code
    MQA
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATEST LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EL-ANA Profiles™ is intended to measure autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), doublestranded DNA (dsDNA), Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P , and Centromere. This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases.
    Device Description
    Not Found
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    K Number
    K002559
    Device Name
    EL-ANA PROFILES-2K1
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2000-09-12

    (26 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATEST LABORATORIES, INC.

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