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10
Appendices
Appendix I: Clinitek Intended Use and Indications for Use
Appendix I: Clinitek Intended Use and Indications for Use
The Clinitek 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
Tests performed using the
Clinitek Analyzer are
intended for
in vitro
diagnostic
use only.
The Clinitek Analyzer
is intended for near patient
(point-of-care) facilities and
centralized laboratory locations.
Summary of Contents for CLINITEK Status
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