Roche cobas c 513 User Manual

Roche Diagnostics
cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0
9Preface
Preface
Use this publication together with the
cobas c 513 analyzer Operator’s Manual.
Intended use and intended purpose
Intended use for US only The cobas c 513 analyzer is a fully automated,
standalone clinical chemistry analyzer intended for the
in-vitro quantitative determination of analytes in body
fluids.
The cobas c 513 analyzer is an in-vitro diagnostic (IVD)
medical equipment.
Intended purpose for EU/EFTA and outside US The cobas c 513 analyzer is a fully automated, discrete
clinical chemistry analyzer intended for the in-vitro
quantitative determination of analytes in body fluids.
It is an IVD device intended to be used in combination
with assays for screening, monitoring (aid in monitoring),
and diagnosis (aid in diagnosis) of diabetes.
The specific disorder is covered by the applicable assays
running on the instrument. The type of specimen to be
used includes serum, plasma, whole blood and
hemolysate, that are used for detecting and/or measuring
analytes covered by the specific assays.
The intended users of this device are trained laboratory
technicians and trained field service engineers
(professional use only).

Roche cobas c 513 Specifications

General

Brand	Roche
Model	cobas c 513
Category	Measuring Instruments
Language	English