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method-sheet-cobas
Please note The measured S100 value of a patient’s sample can vary depending on the testing procedure used. The laboratory finding must therefore always contain a statement on the S100 …
In Vitro Diagnostic Products and Decision Summaries Since Nov 2003
This database search obtains information on all In Vitro Diagnostic Devices cleared or approved since November 2003.
Biomarker-Based Point-of-Care Tests for the Evaluation of Mild ...
Used by the Elecsys S100 test kit, 72,73 the Liaison S100 test kit, 72,74 as well as the Tbit system, 63,64 the S100B protein is expressed from astrocytes after neuronal injury. 7,11,21,30,49,53,59,72 …
ROCHE ELECSYS S100 (100 Test) | Aldeal Lab-Tech Limited
Intended use Immunoassay for the in vitro quantitative determination of S100 (S100 A1B and S100 BB) in human serum. This assay can be used to aid in the management of patients suffering from …
Elecsys® S100 - Roche Diagnostics USA
Access important product documentation including relevant certificates and other resources.
Elecsys® S100 - Roche Diagnostics USA
Intended use Immunoassay for the in vitro quantitative determination of S100 (S100 A1B and S100 BB) in human serum. This assay can be used to aid in the management of patients suffering from …
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY 510(k) Number: k100810 Purpose for Submission: New device Measurand: Calibration verification and assay range …
Roche Diagnostics Elecsys S100 - myHealthbox
The Elecsys S100 assay can be used • to aid in the management of patients suffering from malignant melanoma (Elecsys S100 assay is not suitable for the diagnosis of malignant melanoma) • to aid in …
Performance evaluation of the Roche Elecsys Anti-SARS-CoV-2 S ...
The Elecsys® Anti-SARS-CoV-2 S (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) is an electrochemiluminescence immunoassay (ECLIA), which has been developed for the in vitro …
The metrological traceability of the Elecsys sFlt-1 and Elecsys PlGF was established following the guidelines in EN ISO 17511:2020 In vitro diagnostic medical devices – Requirements for establishing …