6 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
FDA Enforcement
Class III
·Terminated·Roche Diagnostics Operations, Inc.·January 30, 2013
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
FDA Enforcement
Class III
·Terminated·Roche Diagnostics Operations, Inc.·October 22, 2014
Tina-quant Complement C4 ver.2, Catalog 05991994190
FDA Enforcement
Class III
·Terminated·Roche Diagnostics Operations, Inc.·October 21, 2020
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
FDA Enforcement
Class III
·Terminated·Roche Diagnostics Operations, Inc.·October 23, 2019
Albumin Gen.2, Catalog 05166861190
FDA Enforcement
Class III
·Terminated·Roche Diagnostics Operations, Inc.·October 21, 2020
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
FDA Enforcement
Class III
·Terminated·Roche Diagnostics Operations, Inc.·October 23, 2019