Medical Devices

Shimadzu provides a range of Class I & II medical devices. These include the CL Series of LC and LC-MS systems for in vitro diagnostic use, systems that deliver maximum performance and workflow efficiency, resulting in reliable and repeatable data. In addition, the novel Coronavirus Detection Kit for COVID-19*, powered by Ampdirect technology, meets today’s most pressing need: SARS-Cov-2 testing.

  • They support the quality of human life. The concentration of medications in Therapeutic Drug Monitoring (TDM), is assured, even though this may change according to age and health conditions and is dependent on gender, genetic constitution or interferences with other drugs.
  • They help to save lives, particularly when it comes to time-critical situations, e.g. through acute intoxication, medical or drug abuse.
  • They accurately quantitate vitamins, minerals and trace elements
  • They are applied in genomics, proteomics and metabolomics.
 

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LC & LCMS Class I Medical Devices

  • Class I Medical Devices
  • For In Vitro Diagnostic Use
  • Use in the Diagnosis of Disease or in the Cure, Treatment, or Prevention of a Disease
  • Produced Under a Manufacturing Quality System
  • In Compliance with the Federal Food, Drug, and Cosmetic Act
 

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Shimadzu Medical USA offers Class II Medical Devices

  • Crossover Interventional X-ray
  • Interventional Cardiology
  • Radiography / Fluoroscopy
  • Mobile X-ray
  • DR Neutral Solutions
 

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2019 Novel Coronavirus Detection Kit - COVID-19

  • Powered by Shimadzu's AmpdirectTM Technology
  • Simple protocol which eliminates RNA extraction
  • Viral / Universal Transport Medium samples from oropharyngeal and nasal swabs
  • For In Vitro Diagnostic Use
  • Pending FDA Emergency Use Authorization (EUA)* (See Footnote below)
 

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*Pending FDA Emergency Use Authorization (EUA). For in Vitro Diagnostic Use (IVD). This test has been authorized by FDA under an EUA for use by authorized CLIA laboratories or equivalents outside the US. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

 

Industries

For Research Use Only. Not for use in diagnostic procedures.

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