Alere Cholestech LDX Multianalyte Control

  • Model / Serial
    Lot#C2510, C2510A, C2572, C2572A, C2593, and C2593A.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
  • Product Description
    Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 || Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot C3091 and Lot C3091A
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. || Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
  • Manufacturer
  • Model / Serial
  • Product Description
    In-vitro diagnostics - equipment / products for clinical chemistry
  • Manufacturer
  • Model / Serial
    88769 | C2510, C2510A, C2572, C2572A, C2593, C2593A
  • Product Description
    IVD: Multiple clinical chemistry analyte IVD, control
  • Manufacturer
  • Model / Serial
  • Product Description
    Alere Cholestech LDX Multianalyte Control
  • Manufacturer
  • Model / Serial
    Alere Cholestech LDX Multianalyte Control (An in vitro diagnostic medical device used to monitor the performance of total cholesterol (TC), high density lipoprotein (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System)Catalogue Number: CT88769Lot Numbers: C2572, C2572A, C2593 & C2593AARTG Number: 160951
  • Manufacturer