2 results
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15ms
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Sources: EU EUDAMED, US FDA
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021