3 results
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6ms
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Sources: EU EUDAMED, US FDA
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 18, 2013
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
FDA Enforcement
Class I
·Terminated·Beckman Coulter Inc.·November 28, 2018
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
FDA Enforcement
Class I
·Terminated·Beckman Coulter Inc.·November 28, 2018