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Found 10 results
510(k) Data Aggregation
K Number
K021541Device Name
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
Manufacturer
PERKINELMER LIFE SCIENCES
Date Cleared
2002-10-28
(171 days)
Product Code
JNB, CDR, JJE
Regulation Number
862.1555Why did this record match?
Product Code :
JNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoGram PKU Tandem Mass Spectrometry Kit is intended for screening for Phenvlketonuria (PKU). It involves the quantitative determination of phenvlalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.
Device Description
The assay involves the extraction of dried blood spots with a solution containing stable, isotopically labeled internal standards. The response of each amino acid relative to the isotopically labeled standards in the kit is proportional to their actual concentration. The analysis of the material is performed on a tandem mass spectrometer. Control material contained in the kit allows for verification of performance for the test run.
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K Number
K003584Device Name
NEOLYNX SCREENING APPLICATION MANAGER
Manufacturer
MICROMASS, INC.
Date Cleared
2001-03-19
(119 days)
Product Code
JNB
Regulation Number
862.1555Why did this record match?
Product Code :
JNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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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?
Product Code :
JNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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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?
Product Code :
JNB
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
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K Number
K982307Device Name
WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
Manufacturer
WALLAC, INC.
Date Cleared
1999-02-02
(216 days)
Product Code
JNB
Regulation Number
862.1555Why did this record match?
Product Code :
JNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Leucine Test is for the quantitation of leucine, and valine in blood specimens dried on filter paper. It is intended for use as a primary test for screening babies for Maple Syrup Urine Disease.
Device Description
Not Found
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K Number
K974047Device Name
ACCUWELL PHENYLALANINE ASSAY
Manufacturer
NEOMETRICS, INC.
Date Cleared
1997-12-05
(42 days)
Product Code
JNB
Regulation Number
862.1555Why did this record match?
Product Code :
JNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neometrics' ACCUWELL™ Phenylalanine kits are intended to be used for the quantitative measurement of phenylalanine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen for phenylketonuria disease.
Device Description
Not Found
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K Number
K963040Device Name
MANUAL PHENYLALANINE TEST
Manufacturer
BIO-RAD
Date Cleared
1996-10-01
(57 days)
Product Code
JNB
Regulation Number
862.1555Why did this record match?
Product Code :
JNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960437Device Name
RADIAS PHENYLALANINE TEST
Manufacturer
BIO-RAD
Date Cleared
1996-08-16
(198 days)
Product Code
JNB
Regulation Number
862.1555Why did this record match?
Product Code :
JNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961515Device Name
QUANTASE PHENYLALANINE ASSAY
Manufacturer
SHIELD DIAGNOSTICS, LTD.
Date Cleared
1996-06-12
(63 days)
Product Code
JNB
Regulation Number
862.1555Why did this record match?
Product Code :
JNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K943547Device Name
PHENYLALANINE TEST KIT
Manufacturer
ISOLAB, INC.
Date Cleared
1996-01-26
(554 days)
Product Code
JNB
Regulation Number
862.1555Why did this record match?
Product Code :
JNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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