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510(k) Data Aggregation
K Number
K000754Device Name
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
Manufacturer
QUANTASE LTD.
Date Cleared
2000-06-19
(103 days)
Product Code
JNB
Regulation Number
862.1555Why did this record match?
Applicant Name (Manufacturer) :
QUANTASE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990644Device Name
QUANTASE TOTAL GALACTOSE SCREENING ASSAY
Manufacturer
QUANTASE LTD.
Date Cleared
1999-06-21
(115 days)
Product Code
JIA
Regulation Number
862.1310Why 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
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K Number
K990654Device Name
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
Manufacturer
QUANTASE LTD.
Date Cleared
1999-06-21
(112 days)
Product Code
JIA
Regulation Number
862.1310Why 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
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K Number
K984463Device Name
QUANTASE PHE/GAL SCREENING ASSAY
Manufacturer
QUANTASE LTD.
Date Cleared
1999-02-16
(62 days)
Product Code
JNB, JIA, JIX, JJY
Regulation Number
862.1555Why 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
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