Device typeNewborn metabolic screen/congenital disorder IVD, kit, spectrophotometry: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of a clinical specimen for one or more congenital or metabolic disorders of the newborn, using a spectrophotometry method. It typically utilizes whole-blood neonate specimens dried on filter paper, and the analytes detected may include neonatal thyroxine (neonatal T4), neonatal thyroid stimulating hormone (neonatal TSH), 17-hydroxyprogesterone, immunoreactive trypsinogen, and various enzymes and/or amino acids, as indicators of congenital hypothyroidism, adrenal hyperplasia, cystic fibrosis, lysosomal storage disorders (LSDs), or other metabolic disorders.
FDA categoryAcid-Sphingomyelinase (Asm) Newborn Screening Test System, Alpha-D-Galactosidase A (Gla) Newborn Screening Test System, Alpha-D-Glucosidase (Gaa) Newborn Screening Test System, Alpha-L-Iduronidase (Idua) Newborn Screening Test System, ß-Galactocerebrosidase (Galc) Newborn Screening Test System, ß-Glucocerebrosidase (Gba) Newborn Screening Test System
Device ID06438147411672
Catalog number3093-004U
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information