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510(k) Data Aggregation

    K Number
    K070062
    Device Name
    COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
    Manufacturer
    DIESSE DIAGNOSTICA SENESE S.P.A
    Date Cleared
    2007-07-30

    (206 days)

    Product Code
    LIO, JTW
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIESSE DIAGNOSTICA SENESE S.P.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp. Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp Uriset preservative tubes: Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory. Swab set General Use: Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.
    Device Description
    Coproset: disposable in vitro diagnostic device for the collection and transportation of stool samples and the enrichment of pathogenic organisms present in the sample. Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp. Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp. Uriset Preservative tubes with holder: Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory. Swab set General use: Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.
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    K Number
    K050590
    Device Name
    ENZY-WELL SYPHILIS IGG, MODEL 91106
    Manufacturer
    DIESSE DIAGNOSTICA SENESE S.P.A
    Date Cleared
    2006-08-10

    (520 days)

    Product Code
    LIP
    Regulation Number
    866.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIESSE DIAGNOSTICA SENESE S.P.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the qualitative detection of IgG antibodies to Treponema pallidum in human serum by a manual technique. The test may be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum. For in vitro diagnostic use only.
    Device Description
    ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the qualitative detection of IgG antibodies to Treponema pallidum in human serum/ plasma. The test may be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum. The ENZY-WELL SYPHILIS IgG test is based on the ELISA technique (Enzyme-linked immunosorbent assay). Diluted patient sample is incubated in microplate wells coated with T. pallidum. During this incubation specific immunoglobulins, if present, bind to the antigen on the well. After washing, to eliminate unbound proteins, a second incubation is performed with the conjugate, composed of human IgG monoclonal antibodies labeled with peroxidase. After washing to remove unbound conjugate from the wells, the substrate is added, which will react to produce color in the presence of the peroxidase. An acidic solution is added to stop the reaction and the absorbance of the developed color is read at 450 nm
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