Roche COBAS 513

Manufacturer: Roche

Model:  COBAS 513

Intended Use – U.S. Only

The cobas® c 513 analyzer is a standalone automated clinical chemistry analyzer designed for the in vitro quantitative determination of analytes in body fluids.

The cobas® c 513 analyzer is an in vitro diagnostic (IVD) medical device.

Intended Use – EU/EFTA and Outside the U.S.

The cobas® c 513 analyzer is a fully automated, dedicated clinical chemistry analyzer designed for the in vitro quantitative determination of analytes in body fluids.

It is an in vitro diagnostic device intended for use in screening, monitoring (monitoring support), and diagnosing (diagnostic support) of diabetes.

The specific disorder is addressed by the applicable tests performed on the instrument. Sample types include serum, plasma, whole blood, and hemolyzed samples, which are used to detect and/or measure analytes covered by the specific tests.

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