LC & LCMS compliant with In Vitro Diagnostic Regulation (IVDR)
Shimadzu offers Liquid Chromatography and Mass Spectrometry medical devices.
What does this mean to your lab?
These instruments are in compliance with the regulation "(EU) 2017/746" of the European Parliament. These instruments are produced under a manufacturing quality system (ISO-13485).
Shimadzu's CL Series
As one of the leaders supplying LC and LCMS solutions in the clinical field, Shimadzu Corporation offers a portfolio of LC (LC-40) and LCMS (8045/8050/8060/8060NX) instruments fulfilling the requirements of the new IVDR (Regulation (EU) 2017/746) which is valid from May 2022. The CL systems/modules (IVDR Class A) can be used by customers for diagnostic purposes.
CL Series Liquid Chromatograph and Mass Spectrometry Listed Devices
(for EU CE-IVD):
| Main Module | P/N | ||
|---|---|---|---|
| LC | Communications | CBM-40 CL | 228-45012-55 |
| Nexera CL Liquid Chromatograph | LC-40D X3 CL | 228-65076-55 | |
| LC-40D XR CL | 228-65000-55 | ||
| LC-40B X3 CL | 228-65078-55 | ||
| Degassing Unit | DGU-405 CL | 228-65019-55 | |
| Nexera CL Autosampler | SIL-40C X3 CL | 228-65120-55 | |
| SIL-40C XR CL | 228-65103-55 | ||
| Nexera CL Column Oven | CTO-40C CL | 228-65202-55 | |
| Valve Unit | FCV-S CL | 228-65600-55 | |
| Nexera CL UV Detector | SPD-40 CL | 228-65312-55 | |
| LCMS | Triple Quad LC-MS/MS | LCMS-8045 CL | 225-31400-55 |
| 225-31800-55 | |||
| LCMS-8050 CL | 225-19600-55 | ||
| 225-19610-55 | |||
| LCMS-8060 CL | 225-27800-55 | ||
| 225-27810-55 | |||
| LCMS-8060NX CL | 225-41600-55 | ||
| 225-41690-55 | |||
| Automation | CLAM automation module | CLAM-2040 CL | 241-18700-55 |
| Software | Software LC&LCMS | LabSolutions CL Ver. 1.40 (DVD) | 225-45811-55 |
| Software LCMS | LabSolutions Insight CL Ver. 1.1 (DVD) | 225-45812-55 | |
| LabSolutions CL/LabSolutions Insight CL license ASSY | 225-45813-55 | ||
| Software LC | LabSolutions CL Single LC (License) | 223-63386-55 | |
| LabSolutions CL Add LC (License) | 223-63387-55 |
NB: These instruments are only available in the target market where the conformity assessment procedure of the product (CE IVDR) is accepted.
These instruments are designed/developed, manufactured, installed and repaired under a certified Quality Management System according EN ISO 13485:2016 for medical devices and related services.