BEUDAMED
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    DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·January 2, 2013

    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¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·March 5, 2014

    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

    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·April 4, 2018

    cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay

    FDA Enforcement
    Class III ·Terminated·Roche Molecular Systems, Inc.·April 1, 2015

    LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. ¿263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities. Within the United States and its territories positive results must be reported to appropriate state/local public health authorities. Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The LightMix¿ Zika rRT-PCR Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of realtime PCR and in vitro diagnostic procedures. The Test is only for use under the Food and Drug Administration s Emergency Use Authorization.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 21, 2016

    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