ARCHITECT DHEA‐S

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
    AMPMDRS

One device with a similar name

Learn more about the data here

  • Model / Serial
    Product Product Name List Number Lot Number UDI ARCHITECT DHEA‐S Reagents 8K27‐20 01316K000 (01) 00380740017446 (17) 180204 (10) 01316K000 (240) 8K2720 01217A000 (01) 00380740017446 (17) 180413 (10) 01217A000 (240) 8K2720 02217D000 (01) 00380740017446 (17) 180624 (10) 02217D000 (240) 8K2720 04117H000 (01) 00380740017446 (17) 181125 (10) 04117H000 (240) 8K2720 ARCHITECT DHEA‐S Reagents 8K27‐25 01216K000 (01) 00380740017453 (17) 180204 (10) 01216K000 (240) 8K2725 01117A000 (01) 00380740017453 (17) 180413 (10) 01117A000 (240) 8K2725 02217C000 (01) 00380740017453 (17) 180617 (10) 02217C000 (240) 8K2725 02317D000 (01) 00380740017453 (17) 180624 (10) 02317D000 (240) 8K2725 02417D000 (01) 00380740017453 (17) 180624 (10) 02417D000 (240) 8K2725 00517F000 (01) 00380740017453 (17) 180902 (10) 00517F000 (240) 8K2725 02817H000 (01) 00380740017453 (17) 181021 (10) 02817H000 (240) 8K2725
  • Product Description
    IVD Test Reagent/Kits, Immunoassay
  • Manufacturer