Henry Schein Urispec Plus - Page 2

User manual Urispec
®
Plus
2
Manual Urispec
®
Plus V2.01 HS USA / 04-19
The Urispec
®
Plus is CLIA waived for Urispec
®
urinalysis reagent strips.
A certicate of CLIA waiver is required to perform the testing in a waived setting.
If the laboratory does not have a Certicate of Waiver, the Application for Certi-
cation (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 certicate of waiver must follow the manufacturer's instruc-
tions for performing the test. If the laboratory modies the instructions, the test
no longer meets the requirements for waived categorization. A modied test is
considered to be high complexity and subject to all CLIA requirements.
A063439 / xxxx