LCMS In Vitro Diagnostic (IVD) Medical Devices

Shimadzu offers Liquid Chromatography and Mass Spectrometry medical devices. 
 

Medical doctor holding a baby

What does this mean to your lab?

These instruments are in compliance with the regulation "Directive 98/79/EC" of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic (IVD) medical devices. 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 (RUO & IVDD), Shimadzu Corporation is preparing to offer a portfolio of LC (LC-40) and LCMS (8045/8050/8060/8060NX) instruments following the new IVDR (Regulation (EU) 2017/746) from May 2022. Until May 2022, the instruments following IVDD (Directive 98/79/EC) listed below can be sold and used (even after May 2022) by customers for their IVD device or in-house device (in-house method).

Please keep visiting our IVD page regularly to discover all the solutions (instruments and reagents) developped to help you implementing new analysis in your lab!  

 
 
 

Shimadzu currently offers Mass Spectrometry and Liquid Chromatography components for in vitro diagnostic applications. To learn more about our CL Series, download the product brochure and contact a local sales representative.

 

 

CL Series Liquid Chromatograph and Mass Spectrometry Listed Devices
(for EU CE-IVD):

Communications CBM-20A CL 228-45012-55
Degassing Unit DGU-20A5R CL 228-45019-55
Nexera CL Liquid Chromatograph LC-20ADXR CL 228-45137-55
Nexera CL Liquid Chromatograph
LC-30AD CL
Options:
Mixer 20 µl (228-45209-41)
Mixer 40 µl (228-45209-42)
Mixer 100 µl (228-45209-43)
Mixer 180 µl (228-45209-44)
Mixer MR300 LPGE (228-45210-42)
Low volume LPGE 30A CL (228-45205-55)
Reservoir switching kit 30A (228-45167-55)
228-45162-55
Nexera CL Autosampler SIL-20ACXR CL 228-45136-55
Nexera CL Autosampler SIL-30AC CL 228-45157-55
Nexera CL Autosampler SIL-30ACMP CL 228-45175-55
Nexera CL Column Oven CTO-30A CL 228-45160-55
Column Oven
CTO-20AC CL
Options:
FCV-32AH CL (228-45166-55)
FCV-36AH CL (228-45206-55)
FCV-34AH (228-45185-58)
Column Management Device (228-37281-41)
Option Box VP (228-45060-58)
228-45010-55
Nexera CL Diode Array Detector SPD-M30A CL 228-45196-55
Valve Unit FCV-32AH CL
FCV-36AH CL
228-45166-55
228-45206-55
Triple Quad LC-MS/MS LCMS-8040 CL 225-19503-55
Triple Quad LC-MS/MS LCMS-8045 CL 225-31800-55
Triple Quad LC-MS/MS LCMS-8050 CL 225-19610-55
Triple Quad LC-MS/MS LCMS-8060 CL 225-27810-55
Ion source LCMS APCI-8030 CL (for LCMS-8040 CL) 225-14271-55
Ion source LCMS APCI-8050 CL (for LCMS-8045/8050/8060 CL) 225-19601-55
Software LC Labsolutions LC CL - Single LC 223-61912-55
Software LC Labsolutions LC CL - Multi LC 223-61913-55
Software LC Labsolutions LC CL - Multi LC-PDA 223-61914-55
Software LC Labsolutions LC CL - Add LC 223-61915-55
Software LC Labsolutions LC CL - Add PDA 223-61916-55
Software LCMS LabSolutions LCMS CL 225-30900-55
CLAM automation module CLAM-2030 CL 241-18500-55

NB: These instruments products are only available in EU area governed by EU IVD Directive 98/79/EC.

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.
 
 
if you are looking for CE-IVD reagent kit, please look at our consumable page: https://www.shimadzu.eu/diagnostic-reagent-kits
 

Contact us for more information

This product may not be available in all countries.

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