HemoCue Albumin 201, Operating Manual

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HemoCue
®
Albumin 201 system Operating Manual
The HemoCue
®
Albumin 201 system consists of the HemoCue Albumin 201 Analyzer and HemoCue Urine Albumin Microcuvettes.
The system provides rapid, simple and reliable quantitative determination of albumin in urine with results that are precise and accurate.
The system can be used for the purpose of screening, for diagnosis, monitoring and supporting the clinical evidence in the treatment
of microalbuminuria.
This manual provides the basic instructions for routine use as well as technical specifications.
Additional information may be obtained from HemoCue America.
The HemoCue Albumin 201 System is classified as Waived under the CLIA Guidelines and can be used by all laboratories holding a CLIA
certificate of waiver. Please note that the complete test procedure should be read before performing the test. If the laboratory modifies the
HemoCue Albumin 201 test procedure, the test no longer meets the requirements for waived categorization. A modified test is considered to
be highly complex and is subject to all applicable CLIA requirements. For information on how to obtain a CLIA Waiver certificate, please refer
to CMS CLIA program.
!
All system components are designed and manufactured to provide maximum safety. Any other use of the system may impair the safety.
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