2 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·October 26, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012