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.
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
Shimadzu Medical USA offers Class II Medical Devices
- Crossover Interventional X-ray
- Interventional Cardiology
- Radiography / Fluoroscopy
- Mobile X-ray
- DR Neutral Solutions