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BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Class B IVD
Bio-Rad Laboratories GmbH
The Quantase™ Neonatal Phenylalanine Screening Assay is a quantitative enzymatic method for the determination of phenylalanine in human newborn dried blood spot specimens collected on Whatman 903 blood collection paper. This test is intended as a screening method for measuring the L-phenylalanine concentration in newborn blood spot specimens. Elevated results are not diagnostic per se of phenylketonuria, but indicate the urgent need for further study of the newborn from which a presumptive positive sample was received. This kit is not intended for use in monitoring the circulating phenylalanine concentrations of phenylketonuric patients for the purpose of assessing dietary control, nor to detect antenatal or maternal PKU.