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    K Number
    K033865
    Device Name
    IDEIA PCE CHLAMYDIA
    Manufacturer
    DAKOCYTOMATION LTD
    Date Cleared
    2004-01-21

    (40 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAKOCYTOMATION LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DakoCytomation Ltd IDEIA™ PCE Chlamydia is an immunoassay utilising dual amplification technology for the qualitative detection of Chlamydia lipopolysaccharide antigen in human urethral and endocervical swabs and male urines.
    Device Description
    Not Found
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