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510(k) Data Aggregation

    K Number
    K070789
    Device Name
    EUROIMMUN ANTI-CCP ELISA
    Manufacturer
    EUROIMMUN US LLC
    Date Cleared
    2007-12-31

    (284 days)

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

    EUROIMMUN US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K061239
    Device Name
    EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
    Manufacturer
    EUROIMMUN US LLC
    Date Cleared
    2007-06-28

    (421 days)

    Product Code
    MYF, MXJ
    Regulation Number
    866.3305
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-HSV-1 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against Herpes simplex virus type 1 (HSV-1) specific glycoprotein C1 in human serum. It is intended for the presumptive diagnosis of type specific HSV-1 infection with EUROIMMUN Anti-HSV-2 EUSA (IgG) in persons suspected of herpes viral infection. The EUROIMMUN Anti-HSV-2 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against herpes simplex virus type 2 (HSV-2) specific glycoprotein G2 in human serum. It is intended for the presumptive diagnosis of type specific HSV-2 infection with EUROIMMUN Anti-HSV-1 EUSA (lgG) in persons suspected of herpes viral infection.
    Device Description
    Not Found
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    K Number
    K070763
    Device Name
    EUROIMMUN ANA IFA: HEP-20-10
    Manufacturer
    EUROIMMUN US LLC
    Date Cleared
    2007-05-22

    (63 days)

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

    EUROIMMUN US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN ANA IFA:HEp-20-10 is an indirect fluorescent antibody test for the qualitative or semiquantitative detection of antibodies against cell nuclei (ANA) in human serum and EDTA-plasma. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K061408
    Device Name
    EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
    Manufacturer
    EUROIMMUN US LLC
    Date Cleared
    2006-10-05

    (136 days)

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

    EUROIMMUN US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Endomysium IFA kit is designed for the semi-quantitative and qualitative determination of antibodies against Endomysium (EMA) in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathies associated with celiac disease in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K060700
    Device Name
    EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
    Manufacturer
    EUROIMMUN US LLC
    Date Cleared
    2006-09-08

    (177 days)

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

    EUROIMMUN US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This test kit is designed for the determination of anti-proteinase 3 antibodies (PR3) in human serum and plasma. This test is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings. This test kit is designed for the determination of anti-myeloperoxidase antibodies (MPO) in human serum and plasma. This test is used as an aid in the differential diagnosis of microscopic polyangitis, Churg-Strauss syndrome and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K051489
    Device Name
    EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
    Manufacturer
    EUROIMMUN US LLC
    Date Cleared
    2006-02-16

    (255 days)

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

    EUROIMMUN US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This test kit is designed for qualitatively or semi-quantitatively determination of anti-Neutrophil cytoplasmic antibodies (ANCA) in serum. These antibodies are associated with Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome and classic polyarteriitis nodosa. For in vitro diagnostics use.
    Device Description
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