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cobas® Zika Test

Nucleic acid test for use on the cobas® 5800/6800/8800 Systems

IVD For in vitro diagnostic use.
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Compatible Instruments

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    Technical Documents

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    cobas® SARS-CoV-2 test kit
    cobas® SARS-CoV-2 Test
    Country Specific Labeling See country-specific product labeling for regulatory status.
    Product image for LightCycler® 96 System
    LightCycler® 96 Instrument Obtain fast, highly sensitive, and reproducible results for qualitative and quantitative detection of nucleic acids and SNP analysis with the LightCycler® 96.
    IVD For in vitro diagnostic use.
    Product image for MagNA Pure 24 System
    MagNA Pure 24 Instrument A fully-automated clinical nucleic acid extraction system that brings you walkaway automation for up to 24 samples. Designed around the real needs of modern laboratories. Prepare up to 24 samples in just over an hour, or run the fast protocol for up to 8 samples in 30 minutes or less. Flexibility starts here.
    IVD For in vitro diagnostic use.
    Product image for MagNA Pure 96 System
    MagNA Pure 96 Instrument High-throughput robotic workstation for fully automated purification of nucleic acids from up to 96 samples. Take your lab to new levels of efficiency. Purify DNA and RNA from a wide range of starting materials using magnetic glass particle technology on the MagNA Pure 96 System.
    IVD For in vitro diagnostic use.
    UC-TIB-HSV/VZV
    UC-TIB-HSV/VZV Real time PCR kit for qualitative detection of human Herpes Simplex Virus 1/2 and Varicella Zoster Virus.
    For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems.     Real time PCR kit for qualitative detection of human Herpes Simplex Virus 1/2 and Varicella Zoster Virus. For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems.
    IVD For in vitro diagnostic use.
    cobas p 480 instrument
    cobas p 480 Instrument Improve workflow, reduce the risk of contamination, and make the most of your technician’s time. For support of cobas® 4800/6800/8800 Systems.
    IVD For in vitro diagnostic use.
    cobas® 5800 System
    cobas® 5800 System The cobas® 5800 System makes automation, consolidation, integration and standardization more accessible than ever before.
    IVD For in vitro diagnostic use.
    cobas® 6800 System
    cobas® 6800 System Embrace the future of molecular testing with proven PCR performance. Learn about the cobas® 6800 System’s broad menu of high-quality assays, including HIV, HPV, CT/NG, Hepatitis, CMV, WNV, respiratory infections, and more!
    IVD For in vitro diagnostic use.
    cobas® 8800 System
    cobas® 8800 System Run up to 1,056 tests in an 8-hour shift and experience unparalleled automation - only 3 user interactions per run for up to 4 hours of walk-away time.
    IVD For in vitro diagnostic use.
    cobas s 201 system
    cobas® s 201 system Experience the combination of real-time PCR technology and modular automation in the first multi-dye, nucleic acid amplification technology (NAT) screening system for blood and plasma.
    IVD For in vitro diagnostic use.
    LightCycler® PRO System
    LightCycler® PRO System LightCycler® PRO integrates innovative technology and Roche manufacturing to deliver accurate real-time PCR results
    Country Specific Labeling See country-specific product labeling for regulatory status.
    Product image for LightCycler® 2.0 System
    LightCycler® 2.0 Instrument Monitor amplification of 32 PCR products simultaneously and obtain fast, highly reproducible results with the LightCycler® 2.0 System.
    LSR For life science research only. Not for use in diagnostic procedures.
    LightCycler® 480 System
    LightCycler® 480 Instrument II Obtain fast, highly sensitive, and reproducible results with the LightCycler® 480 System. Amplify your success in medium and high-throughput real-time PCR.
    IVD For in vitro diagnostic use.
    cobas® liat system
    cobas® liat system Bring accurate and reliable PCR results to the POC, enabling answers patients and clinicians need in 20 minutes or less to support triage and patient management.
    Country Specific Labeling See country-specific product labeling for regulatory status.
    cobas z 480 analyzer
    cobas z 480 analyzer The cobas z 480 analyzer is a component of the modular cobas® 4800 System, and can also exist as a standalone instrument for automated amplification and detection of clinical and research assays. The cobas z 480 analyzer offers advanced real-time PCR technology for high-quality results.
    IVD For in vitro diagnostic use.
    cobas prime pre-analytical system
    cobas® prime Pre-analytical System The industry’s leading instruments converge to form a single solution that transforms your operation into a laboratory of the future. This fully automated system consolidates, integrates and standardizes the pre-analytical process to streamline lab operations.
    RUO For Research Use Only. Not for use in diagnostic procedures.
    LightMix<sup>®</sup> Digital EGFR_Ex19del
    LightMix® Digital EGFR_Ex19del Kit with reagents for a maximum of 32 (HiSense plate) or 46 (Universal plate) digital PCR reactions
    TIB MOLBIOL order number: 20-3001-32     Using PCR methodology, an 87 bp fragment (wild-type sequence) covering the EGFR exon 19 deletions is amplified with specific primers. The mutation site is analyzed using two labeled probes: a reference probe (HEX-labeled) and an indel probe (FAM-labeled). The reference probe is designed to bind to the amplicon irrespective of mutation presence, and the indel probe is designed to bind to the wild-type sequence but not to any of the mutated sequences. The PC included in the kit contains 4-6 % synthetic mutant target in wild-type genomic DNA and is equivalent to ~17 ng/µl when dissolved in 60 µl of PCR grade water. It is recommended to always include at least one PC and a No- Template-Control (NTC) (e.g. PCR grade water) in each run.
    RUO For Research Use Only. Not for use in diagnostic procedures.
    LightMix<sup>®</sup> Digital KRAS G12D
    LightMix® Digital KRAS G12D Kit with reagents for a maximum of 32 (HiSense plate) or 46 (Universal plate) digital PCR reactions
    TIB MOLBIOL order number: 20-3003-32     Using PCR methodology, a 72 bp fragment covering the KRAS G12D mutation is amplified with specific primers. The mutation site in the PCR fragment is analyzed using two labeled probes binding competitively to the mutation site. The mutant probe is FAM- labeled, and the wild type (WT) probe is HEX-labeled. The PC included in the kit contains 4-6 % synthetic mutant target in wild-type genomic DNA and is equivalent to ~17 ng/µl when dissolved in 60 µl of PCR grade water. It is recommended to always include at least one PC and a No-Template-Control (NTC) (e.g. PCR grade water) in each run.
    RUO For Research Use Only. Not for use in diagnostic procedures.
    LightMix<sup>®</sup> Digital BRAF V600E
    LightMix® Digital BRAF V600E Kit with reagents for a maximum of 32 (HiSense plate) or 46 (Universal plate) digital PCR reactions
    TIB MOLBIOL order number: 20-3002-32     Using PCR methodology, a 117 bp fragment covering the BRAF V600E mutation is amplified with specific primers. The mutation site in the PCR fragment is analyzed using two labeled probes binding competitively to the mutation site. The mutant probe is FAM- labeled, and the wild type (WT) probe is HEX-labeled. The PC included in the kit contains 4-6 % synthetic mutant target in wild-type genomic DNA and is equivalent to ~17 ng/µl when dissolved in 60 µl of PCR grade water. It is recommended to always include at least one PC and a No-Template-Control (NTC) (e.g. PCR grade water) in each run.
    RUO For Research Use Only. Not for use in diagnostic procedures.
    LightMix<sup>®</sup> Digital PIK3CA E545K
    LightMix® Digital PIK3CA E545K Kit with reagents for a maximum of 32 (HiSense plate) or 46 (Universal plate) digital PCR reactions
    TIB MOLBIOL order number: 20-3004-32     Using PCR methodology, an 83 bp fragment covering the PIK3CA E545K mutation is amplified with specific primers. The mutation site in the PCR fragment is analyzed using two labeled probes binding competitively to the mutation site. The mutant probe is FAM- labeled, and the wild type (WT) probe is HEX-labeled. The PC included in the kit contains 4-6 % synthetic mutant target in wild-type genomic DNA and is equivalent to ~17 ng/µl when dissolved in 60 µl of PCR grade water. It is recommended to always include at least one PC and a No-Template-Control (NTC) (e.g. PCR grade water) in each run.
    RUO For Research Use Only. Not for use in diagnostic procedures.
    LightMix<sup>®</sup> Digital EGFR T790M
    LightMix® Digital EGFR T790M Kit with reagents for a maximum of 32 (HiSense plate) or 46 (Universal plate) digital PCR reactions
    TIB MOLBIOL order number: 20-3000-32     Using PCR methodology, a 113 bp fragment covering the EGFR T790M mutation is amplified with specific primers. The mutation site in the PCR fragment is analyzed using two labeled probes binding competitively to the mutation site. The mutant probe is FAM- labeled, and the wild type (WT) probe is HEX-labeled. The PC included in the kit contains 4-6 % synthetic mutant target in wild-type genomic DNA and is equivalent to ~17 ng/µl when dissolved in 60 µl of PCR grade water. It is recommended to always include at least one PC and a No-Template-Control (NTC) (e.g. PCR grade water) in each run.
    IVD For in vitro diagnostic use.
    UC-TIB-AdV
    UC-TIB-AdV Real time PCR kit for quantification of human Adenovirus.
    For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems.     Real time PCR kit for quantification of human Adenovirus. For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems.
    IVD For in vitro diagnostic use.
    <i><b>Resistance</b>Plus</i><sup>®</sup> MG
    ResistancePlus® MG Multiplex real-time PCR assay for the identification of Mycoplasma genitalium and detection of mutations associated with resistance to azithromycin The ResistancePlus® MG kit simultaneously detects M. genitalium and 5 mutations at positions 2058 and 2059 in the 23S rRNA gene (E. coli numbering) that are associated with resistance to azithromycin (macrolide-based antibiotic).The ResistancePlus® MG kit is a 1-wellreal-timePCR multiplex consisting of 3 readouts. Readout 1 indicates the presence or absence of M. genitalium through detection of the MgPa gene; Readout 2 indicates the presence of a A2058G, A2059G, A2058T, A2058C or A2059C mutation in the 23S rRNA gene; and Readout 3 is an internal control to monitor extraction efficiency and qPCR inhibition. The ResistancePlus® MG kit utilises PlexZyme® and PlexPrime® for specificity and superior multiplexing capability.The assay is validated onsamples extracted using the MagNA Pure 96 System (Roche), MICROLAB STARlet IVD (Hamilton), NUCLISENS® easyMAG® (Biomérieux) and real-time detection on the Roche LightCycler® 480 Instrument II (LC480 II) andcobas z 480 analyser (z480).
    IVD For in vitro diagnostic use.
    <i><b>Resistance</b>Plus</i><sup>®</sup> GC
    ResistancePlus® GC Multiplex real-time PCR assay for the detection of Neisseria gonorrhoeae and markers associated with susceptibility and resistance to ciprofloxacin The ResistancePlus® GC kit simultaneously detects the bacterium Neisseria gonorrhoeae (GC) and the gyrA S91 (wild type) or gyrA S91F (mutant) markers that are associated with susceptibility or resistance to the fluoroquinolone antibiotic, ciprofloxacin.The ResistancePlus® GC kitis a 1-wellreal-timePCR multiplex consisting of 5 readouts: Readout 1) GC opa gene, Readout 2) GC porA gene, Readout 3) gyrA S91 (wild type), Readout 4) gyrA S91F (mutant), and Readout 5) Internal control (to monitor extraction efficiency and PCR inhibition). The ResistancePlus® MG kit utilises PlexZyme® and PlexPrime® for specificity and superior multiplexing capability.The assay is compatible with samples extracted using the MagNA Pure 96 System (Roche), EZ1 Advanced XL (Qiagen), QIAsymphony® SP (QIAGEN) and real-time detection on the LightCycler® 480 Instrument II (LC480 II, Roche), cobas z 480 analyser (z 480).
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HCV
    cobas® HCV Quantitative nucleic acid test for use on the cobas® 4800 System
    Country Specific Labeling See country-specific product labeling for regulatory status.
    cobas® eplex RP 2 panel
    cobas® eplex respiratory pathogen panel 2
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HCV
    cobas® HCV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HIV-1/HIV-2 Qualitative
    cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> WNV Test
    cobas® WNV Test Nucleic acid test for use on the cobas® 6800/8800 Systems
    IVD For in vitro diagnostic use.
    cobas® eplex blood culture identification Gram-Negative panel
    cobas® eplex blood culture identification gram-negative (BCID-GN) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> PIK3CA Mutation Test
    cobas® PIK3CA Mutation Test
    IVD For in vitro diagnostic use.
    cobas® eplex blood culture identification Fungal Pathogen panel
    cobas® eplex blood culture identification gram-positive (BCID-GP) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> ADV/hMPV/EV-RV UC
    cobas® ADV/hMPV/EV-RV UC Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems The cobas® ADV/hMPV/EV-RV UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is an automated, multiplex, real-time reverse transcription polymerase chain reaction (PCR) assay for the timely in vitro qualitative detection and discrimination of human Adenovirus (ADV), Metapneumovirus (hMPV) and Enterovirus/Rhinovirus (EV-RV).This test is intended for the use as an aid in the diagnosis and differentiation of ADV, hMPV and EV-RV in nasopharyngeal swab specimens from patients with signs and symptoms of a respiratory infection.The results from cobas® ADV/hMPV/EV-RV UC must be interpreted within the context of all relevant clinical, epidemiological, and laboratory data. Negative results do not preclude viral infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The cobas® ADV/hMPV/EV-RV UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is intended for professional use in a clinical laboratory setting.
    IVD For in vitro diagnostic use.
    cobas omni Utility Channel
    cobas omni Utility Channel For use on the cobas® 5800/6800/8800 Systems Consolidate and automate IVD and LDTs on one platform with the cobas omni Utility Channel—maximise laboratory space, minimise capital investment, and decrease operational costs.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> cfDNA Sample Preparation Kit
    cobas® cfDNA Sample Preparation Kit The cobas® cfDNA Sample Preparation Kit is used for manual sample preparation to isolate circulating cell-free DNA (cfDNA) from plasma samples.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> EGFR Mutation Test v2
    cobas® EGFR Mutation Test v2
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> WNV Test
    cobas® WNV Test Nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    RUO For Research Use Only. Not for use in diagnostic procedures.
    <b>cobas</b><sup>®</sup> HBV RNA
    cobas® HBV RNA Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® HBV RNA for use on the cobas® 5800/6800/8800 Systems (cobas® HBV RNA) is an automated real-time RT-PCR assay for the in vitro quantitative detection of circulating HBV RNA in EDTA plasma and serum. cobas® HBV RNA is intended for research use only and is not for use in diagnostic procedures. cobas® HBV RNA can be used to support scientific research to understand the potential use of this new biomarker.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> KRAS Mutation Test
    cobas® KRAS Mutation Test
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> SARS-CoV-2 &amp; Influenza A/B
    cobas® SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® SARS-CoV-2 & Influenza A/B assay for use on the cobas® 5800/6800/8800 Systems (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID‑19 by their healthcare provider. cobas® SARS-CoV-2 & Influenza A/B is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans and is not intended to detect influenza C.RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.cobas® SARS-CoV-2 & Influenza A/B is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 5800/6800/8800 Systems.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> EBV
    cobas® EBV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> SARS-CoV-2 &amp; Influenza A/B v2
    cobas® SARS-CoV-2 & Influenza A/B v2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® SARS-CoV-2 & Influenza A/B v2 assay for use on the cobas® 5800/6800/8800 Systems (cobas® SARS-CoV-2 & Influenza A/B v2) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. cobas® SARS-CoV-2 & Influenza A/B v2 is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans and is not intended to detect influenza C.RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.cobas® SARS-CoV-2 & Influenza A/B v2 is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 5800/6800/8800 Systems.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> SARS-CoV-2 &amp; Influenza A/B
    cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® liat system Detect and differentiate SARS-CoV-2, influenza A and influenza B in 20 minutes from a single sample and in just one RT-PCR test for use on the cobas® liat system.
    IVD For in vitro diagnostic use.
    <b>cobas<sup>®</sup></b> Malaria
    cobas® Malaria for use on the cobas® 5800/6800/8800 Systems
    RUO For Research Use Only. Not for use in diagnostic procedures.
    <b>cobas</b><sup>®</sup> SARS-CoV-2 Duo
    cobas® SARS-CoV-2 Duo Qualitative and quantitivate test for use on the cobas® 5800/6800/8800 Systems Proposed UseThe cobas® SARS-CoV-2 Duo for use on the cobas® 6800/8800 Systems (cobas® SARS-CoV-2 Duo) is an automated real-time RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens.cobas® SARS-CoV-2 Duo is intended for research use only and is not for use in diagnostic procedures.
    LSR For life science research only. Not for use in diagnostic procedures.
    <b>cobas<sup>®</sup> omni</b> Optimization Kit
    cobas omni Optimization Kit cobas omni Optimization Kit - Rapid optimization of LDTs for consolidation on the cobas omni Utility Channel - For Research Use Only. Not for use in diagnostic procedures.
    IVD For in vitro diagnostic use.
    cobas® eplex blood culture identification Fungal Pathogen (BCID-FP) panel
    cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
    <b>cobas</b><sup>®</sup> EZH2 Mutation Test
    cobas® EZH2 Mutation Test The cobas® EZH2 Mutation Test is a real-time allele-specific PCR test for qualitative detection of single nucleotide mutations for Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the EZH2 gene in DNA extracted from formalin fixed paraffin embedded (FFPE) human follicular lymphoma tumor tissue specimens. The cobas® EZH2 Mutation Test is intended for the identification of follicular lymphoma patients with an EZH2 mutation for treatment with TAZVERIK™ (tazemetostat), in accordance with the approved therapeutic product labeling.Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.
    <b>cobas</b><sup>®</sup> Paraflu 1-4 UC
    cobas® Paraflu 1-4 UC Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas<sup>®</sup></b> MPXV
    cobas® MPXV Qualitative assay for use on the cobas® 6800/8800 Systems cobas® MPXV for use on the cobas® 6800/8800 Systems (cobas® MPXV) is a real-time PCR assay for the qualitative detection of DNA from Monkeypox virus (MPXV, clade I/II) in human lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) from individuals suspected of monkeypox infection by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42.U.S.C. §263a, that meet requirements to perform moderate or high complexity tests.Results are for the identification of monkeypox virus (clade I/II) DNA, which is generally detectable in human pustular or vesicular lesion specimens during the acute phase of infection. Positive results are indicative of the presence of monkeypox virus (clade I/II) DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results obtained with this device do not preclude monkeypox virus (clade I/II) infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.Laboratories within the United States and its territories are required to report test results to the appropriate public health authorities. cobas® MPXV is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 6800/8800 Systems.cobas® MPXV is only for use under the Food and Drug Administration’s Emergency Use Authorization.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Babesia
    cobas® Babesia Nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HSV 1 and 2 Test
    cobas® HSV 1 and 2 Test for use on the cobas® 4800 System
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> TV/MG
    cobas® TV/MG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Babesia
    cobas® Babesia Nucleic acid test for use on the cobas® 6800/8800 Systems INTENDED USE #1 CE-IVDThe cobas® Babesia test for use on the cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Whole blood samples from all donors may be screened as individual samples or in pools comprised of aliquots of individual samples.This test is not intended for use as an aid in diagnosis of Babesia infection.This test is not intended for use on samples of cord blood.This test is not intended for use on cadaveric blood specimens.INTENDED USE #2 US-IVDThe cobas® Babesia test for use on the ccobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Whole blood samples from all donors may be screened as individual samples or in pools comprised of aliquots of not more than six individual samples.This test is not intended for use as an aid in diagnosis of Babesia infection.This test is not intended for use on samples of cord blood.This test is not intended for use on cadaveric blood specimens.
    <b>cobas</b><sup>®</sup> SARS-CoV-2
    cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® liat system Inform decisions at the POC with targeted RT-PCR SARS-CoV-2 test results in 20 minutes for both asymptomatic and symptomatic individuals using the cobas® liat system.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Strep A
    cobas® Strep A Nucleic acid test for use on the cobas® liat system With lab-quality results in ~15 minutes, cobas® Strep A, for use on the cobas® liat system aids clinicians to make immediate, informed treatment decisions.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Influenza A/B &amp; RSV
    cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® liat system Diagnose and differentiate influenza A/B & RSV for effective clinical management and infection control with the POC multiplex PCR test for use on the cobas® liat system.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> DNA Sample Preparation Kit
    cobas® DNA Sample Preparation Kit The cobas® DNA Sample Preparation Kit is used for manual sample preparation to isolate genomic DNA from formalin-fixed paraffin-embedded tumor tissue (FFPET) samples.
    RUO For Research Use Only. Not for use in diagnostic procedures.
    <b>cobas</b><sup>®</sup> SARS-CoV-2 Variant Set 1
    cobas® SARS-CoV-2 Variant Set 1 Qualitative assay for use on the cobas® 6800/8800 Systems The cobas® SARS-CoV-2 Variant Set 1 for use on the cobas® 6800/8800 Systems is an automated, multiplex, real-time RT-PCR assay for the qualitative detection and differentiation of SARS-CoV-2 mutations E484K, N501Y and deletion HV-69/70 in e.g., nasal and nasopharyngeal swab specimens from patients with known SARS-CoV-2 infection to support the understanding of variant epidemiology for Population Health Management.The cobas® SARS-CoV-2 Variant Set 1 assay is intended for research use only and is not for use in diagnostic procedures.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Cdiff
    cobas® Cdiff Nucleic acid test for use on the cobas® liat system Provide accurate, on-demand results in 20 minutes for the detection of toxigenic C. diff with the POC PCR test for use on the cobas® liat system.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> CT/NG
    cobas® CT/NG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> 4800 BRAF V600 Mutation Test
    cobas® 4800 BRAF V600 Mutation Test
    IVD For in vitro diagnostic use.
    digital lightcycler product thumbnail
    Digital LightCycler® System Unleash the true power of digital PCR
    IVD For in vitro diagnostic use.
    Product Image for cobas® 4800 system
    cobas® 4800 system Discover real-time PCR amplification and detection featuring fully automated sample preparation, high quality nucleic acid extraction and robust engineering.
    IVD For in vitro diagnostic use.
    <b>cobas<sup>®</sup> eplex</b> system
    cobas® eplex system The cobas eplex system integrates the entire process from order-to-report to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics.
    IVD For in vitro diagnostic use.
    Roche Cell Collection Medium
    Roche Cell Collection Medium Roche Cell Collection Medium is designed for the preservation and transport of cells to be used in molecular testing and/or for the preparation of cytology slides.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HEV
    cobas® HEV Nucleic acid test for use on the cobas® 5800/6800/8800 Systems The cobas® HEV test for use on cobas® 5800/6800/8800 Systems is a qualitative in vitro nucleic acid amplification test for the direct detection of hepatitis E virus (HEV) RNA (genotypes 1-4) in human plasma.This test is intended for use to screen donor samples for HEV RNA in plasma samples from individual human donors, including donors of whole blood, blood components (red cells, platelets, and plasma), and other living donors. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples.This test is not intended for use on samples of cord blood.This test is not intended for use as an aid in diagnosis for HEV.
    <b>cobas</b><sup>®</sup> SARS-CoV-2 Duo
    cobas® SARS-CoV-2 Duo Qualitative and quantitative assay for use on the cobas® 6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Factor II and Factor V Test
    cobas® Factor II and Factor V Test
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Plasma Separation Card
    cobas® Plasma Separation Card The cobas® Plasma Separation Card is intended for the collection and stabilization of dried plasma from whole blood specimens, for subsequent in vitro diagnostic examination.
    IVD For in vitro diagnostic use.
    <b>cobas<sup>®</sup></b> Respiratory flex
    cobas® Respiratory flex Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Influenza A/B &amp; RSV UC
    cobas® Influenza A/B & RSV UC Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MPX
    cobas® MPX Multiplex HIV, HCV & HBV nucleic acid test for use on the cobas® 6800/8800 Systems
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> 4800 CT/NG v2.0
    cobas® 4800 CT/NG v2.0 The cobas® CT/NG v2.0 Test is an automated, in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting) clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> HCV GT
    cobas® HCV GT HCV genotyping test for use on the cobas® 4800 System cobas® HCV GT is an in vitro nucleic acid amplification test for the qualitative identification of Hepatitis C Virus (HCV) genotypes 1 to 6 and genotype 1 subtypes a and b in human EDTA plasma or serum from individuals with chronic HCV infection, using the cobas® 4800 system: the cobas® x 480 instrument for automated sample processing and the cobas® z 480 analyzer for automated amplification and detection. cobas® HCV GT is intended for use in selecting individuals with chronic HCV infection for antiviral therapy and in determining the duration of therapy regimens according to the antiviral therapy prescribing information.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MPX
    cobas® MPX Multiplex HIV, HCV & HBV nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    RUO For Research Use Only. Not for use in diagnostic procedures.
    <b>cobas<sup>®</sup></b> HDV
    cobas® HDV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems cobas® HDV for use on the cobas® 5800/6800/8800 Systems (cobas® HDV) is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis D virus (HDV) RNA in human EDTA plasma or serum. cobas® HDV is intended for research use only and is not for use in diagnostic procedures. cobas® HDV can be used to support scientific research to understand the potential use of this biomarker.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MAI
    cobas® MAI for use on the cobas® 5800/6800/8800 Systems cobas® MAI for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Mycobacterium avium and Mycobacterium intracellulare DNA in human respiratory specimens including raw sputum, and digested and decontaminated (N-acetyl-L-cysteine/NaOH [NALC-NaOH]-treated) sputum and bronchoalveolar lavage (BAL) samples. This test is intended for use in conjunction with mycobacterial culture as an aid in the diagnosis of pulmonary M. avium and M. intracellulare complex (MAC) infections.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MTB
    cobas® MTB for use on the cobas® 5800/6800/8800 Systems cobas® MTB for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Mycobacterium tuberculosis complex (MTBC) DNA, in human respiratory specimens; including raw sputum, and digested and decontaminated (N-acetyl-L- cysteine/NaOH [NALC-NaOH]-treated) sputum and bronchoalveolar lavage (BAL) samples. This test is for use with specimens from patients who are suspected of Mycobacterium tuberculosis infection, and who are not taking antituberculosis therapy. This test is intended as an aid in the diagnosis of pulmonary tuberculosis, and in conjunction with other laboratory findings, as well as clinical signs and symptoms.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> DPX
    cobas® DPX Duplex HAV & parvovirus B19 nucleic acid test for use on the cobas® 6800/8800 Systems The cobas® DPX test is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (HAV) genotypes I, II, and III RNA in human plasma.This test is intended for use as an in-process test to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma. Plasma from all donors or manufacturing pools may be tested as individual samples or in pools comprised of aliquots of individual samples.This test is not intended for use on samples of cord blood.This test is not intended for use as an aid in diagnosis for parvovirus B19 or HAV.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> MTB-RIF/INH
    cobas® MTB-RIF/INH for use on the cobas® 5800/6800/8800 Systems cobas® MTB-RIF/INH for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of rifampicin-resistance associated mutations of the rpoB gene, and isoniazid-resistance associated mutations in the katG and inhA genes, of Mycobacterium tuberculosis, from human respiratory specimens. The test is intended for use on raw sputum, and digested and decontaminated (N-acetyl-L-cysteine/ NaOH treated) sputum and bronchial alveolar lavage (BAL) samples, that tested positive for Mycobacterium tuberculosis complex (MTBC) by cobas® MTB. This test is intended for use in conjunction with culture and drug susceptibility testing, and as a reflex test together with cobas® MTB, as an aid in the diagnosis of infection with a multidrug resistant M. tuberculosis (MDR-TB).
    IVD For in vitro diagnostic use.
    <b>cobas<sup>®</sup></b> TaqScreen MPX Test, version 2.0
    cobas® TaqScreen MPX Test, version 2.0
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> BKV
    cobas® BKV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    GLU For general laboratory use.
    FLOW Solution
    FLOW Solution Go with the FLOW Solution from Roche, for complete workflow standardization and data automation throughout testing.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> CMV
    cobas® CMV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
    IVD For in vitro diagnostic use.
    symbol for cobas synergy software
    cobas® Synergy Software For use with cobas® 6800/8800 Systems, cobas® 5800 system, Microlab® STAR IVD, and Microlab® STARlet IVD High capacity pooling and archiving of blood donations
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> CMV Test
    cobas® CMV Test Quantitative nucleic acid test for use on the cobas® 4800 System cobas® CMV is an in-vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (CMV) DNA in human EDTA plasma. cobas® CMV is intended for use as an aid in the diagnosis and management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. The test can be used in these populations to assess the need to initiate antiviral treatment. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results from cobas® CMV must be interpreted within the context of all relevant clinical and laboratory findings.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> CHIKV/DENV
    cobas® CHIKV/DENV Nucleic acid test for use on the cobas® 6800/8800 Systems cobas® CHIKV/DENV for use on the cobas® 6800/8800 Systems is a qualitative in vitro test for the direct detection of chikungunya virus (CHIKV) RNA and dengue virus (DENV) serotypes 1-4 RNA in human plasma.The test is intended for use to screen donor samples for CHIKV RNA or DENV RNA alone or to simultaneously screen for both CHIKV and DENV RNA in plasma from individual human donors, including donors of whole blood, blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples.This test is not intended for use of samples of cord blood.This test is not intended for use as an aid in diagnosis for CHIKV or DENV.
    IVD For in vitro diagnostic use.
    <b>cobas</b><sup>®</sup> Zika Test
    cobas® Zika Test Nucleic acid test for use on the cobas® 6800/8800 Systems
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