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Shimadzu Scientific Instruments, Inc.. (4/1/14). "Press Release: Shimadzu Registers HPLC and LCMS Instruments as Class I Medical Devices with Food and Drug Administration".

Region Region United States (USA)
Organisations Organisation Shimadzu U.S.A. Manufacturing Inc. (SUM)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product LC-30 CL system
  Product 2 LCMS-8050 CL triple quadrupole LC-MS/MS system
     


In response to a growing need for analytical measurement in healthcare applications, Shimadzu Corporation, Japan, has registered several of the company's high-performance liquid chromatographs (HPLC) and high-performance liquid chromatograph mass spectrometers (LCMS) as Class I medical devices with the Food and Drug Administration. These are the first Shimadzu analytical instruments registered with the FDA as medical devices.

The use of analytical devices in medical screenings and disease prevention has been on the rise in recent years. Starting in July 2011, the FDA required manufacturers to register analytical instruments as Class I medical devices to ensure their accuracy and reliability when used in healthcare applications.

The following Shimadzu instruments have been registered as Class I medical devices:

LC-20 CL and LC-30 CL HPLCs
Single-quad LCMS-2020 CL
Triple-quad LCMS-8030 CL, LCMS-8040 CL and LCMS-8050 CL

The registered instruments were designed in Shimadzu Corporation's head office (Sanjo Works, Japan) and manufactured at Shimadzu USA Manufacturing (SUM) located in Canby, Ore. Both facilities obtained ISO 13485 certification, the globally recognized international quality management standard for medical equipment, in 2013. SUM is conducting manufacturing of the medical devices mentioned under the FDA regulation 21 CFR 820.

   
Record changed: 2016-03-19

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