Henry Schein Urispec Plus User Manual page 2

User manual Urispec Plus
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The Urispec Plus is CLIA waived for Urispec urinalysis reagent strips.
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A certificate of CLIA waiver is required to perform the testing in a waived setting.
If the laboratory does not have a Certificate of Waiver, the Application for Certi-
fication (Form CMS-116), can be obtained at http://www.cms.hhs.goc/clia/. The
form should be mailed to the address of the local State Agency of the State in
which the laboratory resides (http://www.cms.hhs.gov/clia/ssa-map.asp).
Laboratories with a certificate of waiver must follow the manufacturer's instruc-
tions for performing the test. If the laboratory modifies the instructions, the test
no longer meets the requirements for waived categorization. A modified test is
considered to be high complexity and subject to all CLIA requirements.
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Manual Urispec Plus V2.01 HS USA / 04-19
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