Bio-Rad Quantase™ Neonatal Phenylalanine Screening Kit

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

BIO-RAD LABORATORIES (SINGAPORE) PTE LTD

Class:

Class B IVD

Manufactured by:

Bio-Rad Laboratories GmbH

Therapeutic area:

Clinical chemistry

Therapeutic indications:

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.

Product summary:

Models: Quantase Neonatal Phenylalanine Screening Assay kits - 5325052, Quantase Neonatal Phenylalanine Screening Assay kits - 5325053, Enzyme Reagent 4 vials - 5325067 / 5325041, Enzyme Reagent Diluent 1 x 16ml - 5325068, Enzyme Reagent Diluent 1 x 62ml - 5325042, Colour Reagent 1 x 55ml - 5325070, Colour Reagent 1 x 220ml - 5325044, Coenzyme Reagent 4 vials - 5325069 / 5325044, Blood Spot Standards & Controls - 5326130, Quantase Neonatal Accessory kit Elution Buffer, Filer & Assay Plates - 5325036 / 5325037, Quantase Neonatal Accessory kit filter plates - 5325038, Quantase Neonatal Accessory kit assay plates - 5325039, Quantase Neonatal Accessory kit elution buffer - 5325040, Vacuum manifold for 96 well microtitre plates - 5325025

Authorization date:

2013-01-04