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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