Device Recall Perkin Elmer NEOBASE NONDERIVATIZED MSMS KIT

  • Modelo / Serial
    Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. || This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA