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Introduction
1 Introduction
1.1 Intended purpose
The DocUReader 2 Pro is a semi-automatic urine test strip analyzer and provides
qualitative and semi-quantitative parameter concentration values in human
urine. The analyzer evaluates dedicated LabStrip urine test strips for preliminary
screening.
The product is designed for professional use and may be used in a near-patient
environment as an in vitro diagnostic medical device.
1.2 Indications for use
The DocUReader 2 Pro urine test strip analyzer is a bench top IVD designed to
be used exclusively with LabStrip U11 Plus, and LabStrip U mALB/CREA urine
test strips manufactured by 77 Elektronika Kft.
LabStrip U11 PLUS multiparameter urine test strips
The system performs the qualitative measurement of relevant properties of Ni-
trite (Nit) and the semi-quantitative measurement of relevant properties of the
following urine analytes of the samples:
Bilirubin (Bil), Urobilinogen (Ubg), Ketones (Ket), Ascorbic Acid (Asc), Glucose
(Glu), Protein (Pro), Blood (Bld / Ery), pH, Leukocytes (Leu) and Specific Gravity
(SG).
The system provides a screening test for the early detection of the following
conditions:
•
Liver disease
•
Biliary and hepatic obstructions
•
Carbohydrate metabolism disorders including Diabetes Mellitus
•
Haemolytic disease
•
Urological and nephrological diseases associated with haematuria or haemo-
globinuria
•
Diseases of the kidneys and the urinary tract
•
Pathological shifts in the pH value.
LabStrip U mALB/CREA
The system performs the semi-quantitative measurement of relevant properties
of the following urine analytes:
Albumin (mALB), Creatinine (CREA)
The system provides a screening test for the early detection of the following
conditions:
•
Symptoms of beginning nephropathy
•
Cardio-vascular diseases
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See the MedlinePlus Medical Encyclopedia article on urinalysis for further
details.