Shimadzu Registers HPLC and LCMS Instruments as Class I Medical Devices with FDA
News Apr 01, 2014
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.
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.
Enterome and Nestlé Health Sciences Launch New Diagnostics CompanyNews
Enterome and Nestlé Health Sciences join to create Microbiome Diagnostics Partners, a company that will enable the development and diagnostics for multiple diseases including inflammatory bowel diseases (IBD) and liver diseases.READ MORE
Material From Shellfish Boosts Sensitivity of Diagnostic TestsNews
By adding polydopamine at a key step, the sensitivity of diagnostic tests and bioassays can be increased by as many as 100 to 1,000 times.READ MORE
Comments | 0 ADD COMMENT
18th International Conference and Exhibition on Analytical & Bioanalytical Chromatographic Techniques
Nov 02 - Nov 03, 2017
8th Edition of International Conference on Mass Spectromerty
Mar 12 - Mar 13, 2018