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510(k) Data Aggregation

    K Number
    K231616
    Device Name
    ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
    Manufacturer
    ZEUS Scientific
    Date Cleared
    2023-08-31

    (90 days)

    Product Code
    KTL, PIV
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    KTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZEUS IFA™ nDNA Test System is an indirect immunofluorescence assay utilizing Crithidia luciliae for the qualitative and semi-quantitative determination of anti-native DNA (nDNA) IgG antibodies to DNA in human serum by manual fluorescence microscopy or with ZEUS dIFine®. The presence of nDNA antibodies in conjunction with other serological and clinical findings can be used to aid in the diagnosis of systemic lupus erythematosus (SLE).
    Device Description
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    K Number
    K203599
    Device Name
    Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
    Manufacturer
    Immuno Concepts N.A., Ltd.
    Date Cleared
    2023-05-26

    (898 days)

    Product Code
    KTL
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    KTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Immuno Concepts IgG Anti-nDNA Fluorescent Test System is for in vitro diagnostic use for the qualitative detection and semi-quantitation of anti-nDNA antibodies of the IgG class in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence Semiautomated Microscope. The Immuno Concepts IgG Anti-IDNA Fluorescent Test System is to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.
    Device Description
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    K Number
    K192916
    Device Name
    NOVA Lite DAPI dsDNA Crithidia luciliae Kit
    Manufacturer
    Inova Diagnostics, Inc.
    Date Cleared
    2020-12-11

    (423 days)

    Product Code
    KTL, PIV
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    KTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NOVA Lite® DAPI dsDNA Crithidia luciliae is an indirect immunofluorescent assay for the qualitative and/or semi-quantitative determination of anti-double stranded DNA (dsDNA) IgG antibodies in human serum by NOVA View Automated Fluorescence Microscope or manual fluorescence microscopy. The presence of anti-dsDNA can be used in conjunction with other serological and clinical findings to aid in the diagnosis of systemic lupus erythematosus (SLE). All results generated with NOVA View device must be confirmed by a trained operator.
    Device Description
    The NOVA Lite DAPI dsDNA Crithidia luciliae Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of Anti-dsDNA Antibodies (IgG) in human serum. Samples are diluted 1:10 in PBS and incubated with the antigen substrate (dsDNA on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with antihuman IgG-FITC conjugate. The conjugate contains a DNA-binding blue fluorescent dye, 4',6-diamidino-2phenylindole (DAPI) that is required for NOVA View use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off. Stained slides are read by manual fluorescence microscope or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. dsDNA positive samples exhibit an apple green fluorescence corresponding to areas of the substrate where autoantibody has bound.
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    K Number
    K172244
    Device Name
    EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
    Manufacturer
    Euroimmun US, Inc.
    Date Cleared
    2018-04-20

    (268 days)

    Product Code
    KTL, PIV
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    KTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern test kit is intended for the quantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.
    Device Description
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    K Number
    K172252
    Device Name
    EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
    Manufacturer
    Euroimmun US, Inc.
    Date Cleared
    2018-04-20

    (268 days)

    Product Code
    KTL, PIV
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    KTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern test kit is intended for the qualitative and semiquantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is a sensitive method, used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.
    Device Description
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    K Number
    K011068
    Device Name
    RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
    Manufacturer
    RHIGENE, INC.
    Date Cleared
    2002-04-11

    (367 days)

    Product Code
    KTL
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    KTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K013432
    Device Name
    IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    2001-11-29

    (45 days)

    Product Code
    KTL
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    KTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum. This test system is to be used as an aid in the diagnosis of systemic lupus erythematosus.
    Device Description
    This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum.
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    K Number
    K990916
    Device Name
    INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
    Manufacturer
    STELLAR BIO SYSTEMS, INC.
    Date Cleared
    1999-04-21

    (34 days)

    Product Code
    KTL
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    KTL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Anti-native DNA (nDNA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to nDNA in human serum. Detection of nDNA IgG antibody in humans can be used as an aid in the diagnosis of systemic lupus erythematosus (SLE).
    Device Description
    The nDNA IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to nDNA antigen in human serum.
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