optiview DAB IHC detection

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    NIDFSINVIMA

11 devices with a similar name

Learn more about the data here

  • Model / Serial
    UDI 04015630984039, Lot Numbers: Y19271, Y11625, Y24225, Y15571
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,
  • Product Description
    OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
  • Manufacturer
  • Model / Serial
    see attached pdf
  • Product Classification
  • Product Description
    OptiView DAB IHC Detection Kit 06396500001, ultraView DAB IHC Detection Kit 05269806001, iView DAB IHC Detection Kit 05266157001, ultraView SISH DNP Detection Kit US 05572037001, CINtec PLUS Cytology Kit (CE-IVD) 06889565001, CINtec PLUS Cytology Kit (Canada/Japan) 06889549001, OptiView Amplification Kit 06396518001, OptiView Amplification Kit (250 Test) 06718663001, Hematoxylin II 05277965001, ultraView SISH DNP Detection Kit 05907136001, NEXES VEN IVIEW DAB DET KT JPN-US EXPORT
  • Manufacturer
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