CLINITEK Status+ Analyzer Operator’s Guide 7
Introduction
1 Introduction
The introduction explains how to get started, unpack, and install your
CLINITEK Status
®
+ analyzer. The introduction also includes an overview
of the analyzer.
Intended Use
The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to
use analyzer. It is designed to read only
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and
Clinitest
®
hCG tests.
This analyzer is intended for the measurement of the following in
urine: Albumin, Bibilirubin, 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 (such as diabetes mellitus)
• Liver function
•Pregnancy
Tests perfomed 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.
Summary and Explanation
The urinalysis strips also measure physical characteristics, including
acid-base balance and urine concentration. Test results can be used
along with other diagnostic information to rule out certain disease
states and to determine if microscopic analysis is needed.
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