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NEW YORK (360Dx) – The US Food and Drug Administration has cleared Roche Diagnostics' Cobas e 801 immunoassay analyzer for the in vitro determination of analytes in body fluids, the agency announced recently.

The agency also cleared Roche's Elecsys TSH immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma. TSH measurements are used for diagnosing thyroid or pituitary disorders. The assay is intended for use on the Cobas e analyzers.

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Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.