Appendix I: Clinitek Status®+ Intended Use And Indications For Use - Siemens CLINITEK Status Operator's Manual

10 Appendices
Appendix I: Clinitek Status®+ Intended Use and Indications for Use
Appendix I: Clinitek Status®+ Intended Use and Indications for Use
The Clinitek Status®+ Urine
Chemistry Analyzer is a portable
easy to use analyzer. It is
designed to read only Siemens
Reagent Strips for Urinalysis
and Clinitest® hCG tests.
This analyzer is intended for the
measurement of the following in
urine: Albumin, Bilirubin, Blood
(Occult), Creatinine, Glucose,
Ketone, Leukocytes, Nitrite, pH,
Protein, Protein-to-Creatinine
Ratio, Albumin-to-Creatinine
Ratio, Specific Gravity,
Urobilinogen, and human
Chorionic Gonadotropin (hCG).
These measurements are used
to assist diagnosis in the
following areas:
Kidney Function
Urinary tract infections
Metabolic disorders
(e.g. diabetes mellitus)
Liver Function
Pregnancy
10-22
Tests performed using the
Clinitek Status®+ Analyzer are
intended for in vitro diagnostic
use only.
The Clinitek Status®+ Analyzer
is intended for near patient
(point-of-care) facilities and
centralized laboratory locations.