Roche Diagnostics
COBAS INTEGRA 400 plus analyzer/Cedex Bio HT Analyzer · Software version 3.6/5.1 · Host Interface Manual · Version 1.24
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Intended use for COBAS INTEGRA 400 plus analyzer
The COBAS INTEGRA 400 plus analyzer is a fully
automated, computerized chemistry analyzer. It is
intended for in vitro quantitative or qualitative
determination of a wide range of analytes in various body
fluids.
Intended use for Cedex Bio HT Analyzer
The Cedex Bio HT Analyzer is a fully automated,
computerized analyzer for professional use. It is intended
for determination of a wide range of analytes in various
aqueous solutions like cell culture and fermentation
media.
For use in quality control/manufacturing process only.
Important note
The Cedex Bio HT Analyzer is only intended for the
determination of analytes in aqueous solutions such as
cell culture and fermentation media and is not intended
for any kind of
in vitro
diagnostics applications. Therefore,
the term "patient" does not apply to the
Cedex Bio HT Analyzer and does not appear anywhere
within the software. Instead, all references to "Patient" in
the COBAS INTEGRA 400 plus analyzer software appear
as "Sample" in the Cedex Bio HT Analyzer software. The
Cedex Bio HT Analyzer software does not contain any
references to "patient", "patient mode", or "patient ID" and
does not request patient information.
Symbols and abbreviations
Product names
Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Product name
Descriptor
COBAS INTEGRA 400 plus analyzer
instrument
Cedex Bio HT Analyzer
instrument
Host computer, laboratory information
system or other computer system
connected to the instrument
host
y
Product names