ARCHITECT SHBG

  • Modèle / numéro de série
    List number: 8K26-20, Lot Numbers: 01916E000, 00316F000, 01816G000, 00916I000, 07316I000, 00916L000 ;   List Number: 8K26-25, Lot Numbers: 01816E000, 00216F000, 01716G000, 00816I000, 07216I000
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the countries of : ARGENTINA, ARMENIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI, CANADA, CHINA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DEM. REP. OF THE CON, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HUNGARY, INDIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MONTENEGRO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VIETNAM
  • Description du dispositif
    ARCHITECT SHBG Reagent || The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    USFDA

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