XII. CLIA INFORMATION
General CLIA Information (US Only)
(Please read before testing)
1.
CLIA-waived. Each laboratory or testing site using the PTS Panels
®
test
strips MUST have a CLIA Certificate of Waiver (or other CLIA operating
license) before testing. To obtain a Certificate of Waiver or any other
type of laboratory license, call your state health department or PTS, Inc.
at +1-877-870-5610 (Toll-free) or +1-317-870-5610 for an application
(form CMS 116).
2.
Before you start testing, carefully read all instructions, including quality
control. Failure to follow instructions, including quality control
instructions, will result in high complexity rating and subject the facility to
all applicable CLIA requirements for high complexity testing. For
complete information including performance, please refer to the product
specific package insert and user guide. The glucose and lipid panel test
systems are currently CLIA waived. The original CLIA waiver was under
the analyzer name BioScanner Plus.
3.
CLIA-waived for whole blood (fingerstick and venous EDTA or heparin)
testing only.
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