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8
Quality Control Testing
Information regarding CLIA Waiver
The Clinitek Status system is CLIA
waived for all Bayer branded
urinalysis reagent strips. Cassette
testing is currently categorized as
moderate complexity.
Failure to adhere to the instructions
for use, including instructions for
limitations or intended use, and for
performing QC testing, is
considered off-label use, resulting
in the test being categorized as
high complexity and subject to all
CLIA regulations.
Expected Waiver Performance
Summary tables of the results from
the waiver studies and physician
office studies are included in
Section 10, Appendix F of this
operator's manual.
8-2
132387 Rev. D, 2006-06
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