Cholestech LDX High Sensitivity CReactive Protein (hsCRP) Test Cassette

  • Modelo / Serial
    Catalog #12-807, Lot #C17-6434
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution --- including states of Virginia, Texas and North Carolina, Ohio, Arkansas, Washington, Florida , California and Michigan.
  • Descripción del producto
    Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Cholestech Corp, 3347 Investment Blvd, Hayward CA 94545-3808
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source