Clearview HCG

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
    SATP

13 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
  • Model / Serial
    Model Number: 6028KCV, ABI Lot/Unit Code: 88982
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA and Canada
  • Product Description
    Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA
  • Manufacturer
  • Model / Serial
    Model Number 6026KCV; ABI Lot Code: 87494
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA and Canada
  • Product Description
    Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA
  • Manufacturer
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