Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K000754
    Device Name
    QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
    Manufacturer
    QUANTASE LTD.
    Date Cleared
    2000-06-19

    (103 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTASE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K990644
    Device Name
    QUANTASE TOTAL GALACTOSE SCREENING ASSAY
    Manufacturer
    QUANTASE LTD.
    Date Cleared
    1999-06-21

    (115 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTASE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantase Total Galactose Screening Assay is an enzymatic colorimetric end-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme. The test is intended as a screening the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received. The kit is NOT intended for use in monitoring the circulating concentrations of total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.
    Device Description
    enzymatic colorimetric end-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens
    Ask a Question
    K Number
    K990654
    Device Name
    QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
    Manufacturer
    QUANTASE LTD.
    Date Cleared
    1999-06-21

    (112 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTASE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantase Total Calactose Screening Assay is an enzymatic colorimetric cad-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme. The test is intended as a screening measuring the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received. The kit is NOT intended for use in monitoring the circulating concentrations of total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.
    Device Description
    Not Found
    Ask a Question
    K Number
    K984463
    Device Name
    QUANTASE PHE/GAL SCREENING ASSAY
    Manufacturer
    QUANTASE LTD.
    Date Cleared
    1999-02-16

    (62 days)

    Product Code
    JNB, JIA, JIX, JJY
    Regulation Number
    862.1555
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTASE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantase Phe/Gal Screening Assay is an eazymatic colorinetic cast-point mechod for the decired blood more maciment I he Quantist Parcelling Possy is an enzintate e. siactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme The test is intended as a screening method for measuring the L-phenylalanine and total D(+)galactose I he ust is miched is a screening meason for messaring are not diagnostic per se of phenylkstomuria or galactosemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received. The lit is NOT intended for use in monitoring the circulating concentrations of L-phenylalanine and total I be an is NOT measurer and galactosenic patients respectively, nor to detect ante-natal phenylketonucia and galactosemia or maternal phenylketonuria
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1