3 results
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6ms
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Sources: EU EUDAMED, US FDA
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
FDA Enforcement
Class II
·Terminated·89 NORTH·September 2, 2020
Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·December 5, 2018
Pathfast D-Dimer, Reference number: PF1051-KUS
FDA Enforcement
Class II
·Terminated·Lsi Medience Corporation·November 30, 2016