BEUDAMED
    28 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·March 11, 2026

    The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 14, 2026

    cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·November 27, 2024

    Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·October 2, 2024

    Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001

    FDA Enforcement
    Class II ·Ongoing·Roche Diabetes Care, Inc.·July 3, 2024

    cobas infinity central lab, Material Number 07154003001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 18, 2023

    cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190

    FDA Enforcement
    Class II ·Ongoing·Roche Molecular Systems, Inc.·February 15, 2023

    cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190

    FDA Enforcement
    Class II ·Ongoing·Roche Molecular Systems, Inc.·February 15, 2023

    cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190

    FDA Enforcement
    Class II ·Ongoing·Roche Molecular Systems, Inc.·February 15, 2023

    cobas e801 Immunoassay Analyzer

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·August 17, 2022

    IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·June 2, 2021

    cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190

    FDA Enforcement
    Class II ·Ongoing·Roche Molecular Systems, Inc.·April 21, 2021

    DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·October 14, 2020

    Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·May 26, 2021

    BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·October 14, 2020

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190

    FDA Enforcement
    Class II ·Ongoing·Roche Molecular Systems, Inc.·April 21, 2021

    Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001

    FDA Enforcement
    Class II ·Ongoing·Roche Diabetes Care, Inc.·September 1, 2021

    Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001

    FDA Enforcement
    Class II ·Ongoing·Roche Diabetes Care, Inc.·September 1, 2021

    cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190

    FDA Enforcement
    Class II ·Ongoing·Roche Molecular Systems, Inc.·October 20, 2021