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NEW YORK (360Dx) – A benchtop analyzer from Roche Diagnostics and an immunoassay system from Shenzhen New Industries Biomedical were among the instruments and tests cleared by the US Food and Drug Administration in July, according to the agency.

The FDA granted 510(k) clearance to Roche's Cobas b 101 instrument, as well as the Cobas HbA1c test. The fully automated and self-contained benchtop instrument uses a single-use reagent disc to measure HbA1c from capillary and/or venous whole-blood samples, according to a document filed with the FDA.

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