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510(k) Data Aggregation

    K Number
    K982315
    Device Name
    PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
    Manufacturer
    ALEXON - TREND, INC.
    Date Cleared
    1998-11-18

    (140 days)

    Product Code
    LQP
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXON - TREND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProSpecT® Campylobacter Microplate Assay is an in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures. ProSpecT Campylobacter Microplate Assay is intended for use as an aid in the diagnosis of Campylobacter infections.
    Device Description
    in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen
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    K Number
    K982709
    Device Name
    MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
    Manufacturer
    ALEXON - TREND, INC.
    Date Cleared
    1998-09-03

    (30 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXON - TREND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProSpecT® Cryptosporidium Microplate Assay uses monoclonal antibodies for the qualitative detection of Cryptosporidium Specific Antigen (CSA) in aqueous extracts of fecal specimens.
    Device Description
    ProSpecT® Cryptosporidium Microplate Assay
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    K Number
    K980507
    Device Name
    PROSPECT SHIGA TOXIN MICROPLATE ASSAY
    Manufacturer
    ALEXON - TREND, INC.
    Date Cleared
    1998-04-23

    (72 days)

    Product Code
    GMZ
    Regulation Number
    866.3255
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXON - TREND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProSpecT® Shiga Toxin Microplate Assay is an in vitro microwell EIA for the qualitative detection of Shiga Toxins (Stx 1 and Stx 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. ProSpecT® Shiga Toxin Microplate Assay is intended for use as an aid in the diagnosis of enterohemorrhagic E.coli ( EHEC) infections.
    Device Description
    Not Found
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