15 results
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7ms
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Sources: EU EUDAMED, US FDA
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 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
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
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
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
FDA Enforcement
Class III
·Terminated·Sentinel CH SpA·October 13, 2021
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
FDA Enforcement
Class III
·Ongoing·Sentinel CH SpA·July 14, 2021