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It is an IVD device intended to be used in combination with assays for screening, monitoring (aid in monitoring), diagnosis (aid in diagnosis) and prognosis; additionally, the device can be used to run companion diagnostic tests.
The specific disorder and testing populations are covered by the applicable assays running on the instrument. The type of specimen to be used includes serum, urine, cerebrospinal fluid, oral fluid, hemolysate and plasma that are used for detecting and/or measuring analytes covered by the specific assays. The intended users of this device are trained laboratory technicians and trained field service engineers (professional use only).",
"Country": "XR",
"Code": "Intended Use",
"Name": "Intended Use"
}
]
}
}
]
}
cobas e 411 analyzer for immunoassay tests (disk system)
The cobas e 411 analyzer is a fully automated analyzer that uses a patented ElectroChemiLuminescence (ECL) technology for immunoassay analysis. It is designed for both quantitative and qualitative in vitro assay determinations for a broad range of applications (including anemia; bone, cardiac and tumor markers; critical care; fertility/hormones; maternal care; and infectious diseases). The analyzer is available as a rack or disk sample handling system.
cobas e 411 analyzer for immunoassay tests (rack system)
The cobas e 411 analyzer is a fully automated analyzer that uses a patented ElectroChemiLuminescence (ECL) technology for immunoassay analysis. It is designed for both quantitative and qualitative in vitro assay determinations for a broad range of applications (including anemia; bone, cardiac and tumor markers; critical care; fertility/hormones; maternal care; and infectious diseases). The analyzer is available as a rack or disk sample handling system.
High sensitivity, reliability, and reproducibility of results due to ECL technology
More than 100 assays available1
Up to 18 assays can be run at a throughput of up to 86 tests/h2
9 min STAT applications for emergency sample assays (incl. high-sensitive Troponin T, Creatine-Kinase MB, Myoglobin, Parathyroid Hormone (PTH), and human Chorionic Gonadotropin (hCG)1
Intelligent sample workflow
Carryover-free pipetting of samples to avoid cross-contamination
Automated sample rerun capability
Continuous random access and flexible STAT priority settings
Unique reagent concept
Convenient and error-free handling of cobas e packs
Economic usage with high stabilities and convenient kit sizes
High system reliability
More than 25,000 analyzers installed worldwide3
High uptime of >99%4
Low system maintenance time
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References
Elecsys® Assay menu. Roche Diagnostics International Ltd.
cobas e 411 analyzer. Operator's manual. Roche Diagnostics International Ltd.
Data on file. Roche Diagnostics International Ltd.
Calculation: (365 days / Mean time Between Repair Visit) x (Mean Time for Repair Visit + Travel Time) - Data on file. Roche Diagnostics International Ltd.