Device Recall Perkin Elmer Genetic Screening Processor (GSP)

  • Modelo / Serial
    Serial Numbers: 20210001 through 20210078
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
  • Descripción del producto
    Perkin Elmer Genetic Screening Processor (GSP) || Product Code: 2021-0010 || Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
  • Manufacturer
  • 1 Event

Fabricante

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