3 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
FDA Enforcement
Class III
·Terminated·AdvanDx, Inc.·January 8, 2014
Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·January 16, 2013
Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2013