15 results
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9ms
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Sources: EU EUDAMED, US FDA
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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
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
Albumin Gen.2, Catalog 05166861190
FDA Enforcement
Class III
·Terminated·Roche Diagnostics Operations, Inc.·October 21, 2020
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
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·July 5, 2023
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·July 5, 2023
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).
FDA Enforcement
Class III
·Terminated·Roche Molecular Systems, Inc.·November 7, 2012
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
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
FDA Enforcement
Class III
·Terminated·Roche Diagnostics Corporation·July 10, 2019
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
FDA Enforcement
Class III
·Terminated·Roche Diagnostics Corporation·July 10, 2019
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
FDA Enforcement
Class III
·Terminated·Roche Molecular Systems, Inc.·April 1, 2015
Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC).
FDA Enforcement
Class III
·Terminated·Roche Molecular Systems, Inc.·August 15, 2012
cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
FDA Enforcement
Class III
·Terminated·Roche Molecular Systems, Inc.·July 20, 2016
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
FDA Enforcement
Class III
·Terminated·Roche Molecular Systems, Inc.·January 28, 2015