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510(k) Data Aggregation

    K Number
    K100987
    Device Name
    INVADER MTHFR 677
    Manufacturer
    HOLOGIC, INC.
    Date Cleared
    2011-05-13

    (399 days)

    Product Code
    OMM, DAT
    Regulation Number
    864.7280
    Why did this record match?
    Product Code :

    OMM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invader® MTHFR 677 test is an in vitro diagnostic test intended for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5.10-methylenetetrahydrofolate reductase (MTHFR) gene in isolated genomic DNA obtained from whole blood Potassium EDTA samples from patients with suspected thrombophilia.
    Device Description
    The Invader MTHFR 677 test consists of the following components: MTHFR 677 Oligo Mix Universal Buffer Universal Enzyme Mix No DNA Control MTHFR 677 Wild Type Control MTHFR 677 Heterozygous Control MTHFR 677 Mutant Control Invader Call Reporter™ Software
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    K Number
    K100496
    Device Name
    INVADER MTHFR 1298
    Manufacturer
    HOLOGIC, INC.
    Date Cleared
    2011-04-25

    (427 days)

    Product Code
    OMM, DAT
    Regulation Number
    864.7280
    Why did this record match?
    Product Code :

    OMM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invader® MTHFR 1298 test is an in vitro diagnostic test intended for the detection and genotyping of a single point mutation (A to C at position 1298) of the human 5,10-methylenetetrahydrofolate reductase (MTHFR) gene in isolated genomic DNA obtained from whole blood potassium EDTA samples from patients with suspected thrombophilia.
    Device Description
    The Invader MTHFR 1298 test consists of the following components: MTHFR 1298 Oligo Mix Universal Buffer Universal Enzyme Mix No DNA Control MTHFR 1298 Wild Type Control MTHFR 1298 Heterozygous Control MTHFR 1298 Mutant Control Invader Call Reporter™ Software Invader® MTHFR 1298 Software
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