As such, a waived test
can be used in many non-clinical settings.
com offers a wide range of CLIA waived test
products that can identify and help control potentially serious conditions such as Hyperlipidemia, Diabetes, Osteoporosis, Colon Cancer, Prostate Cancer and Thyroid Disease.
The 34% fewer sites from 1996 to 2006 included in the AOT group is likely due to the increase in the availability of simple, point-of-care tests that have been waived from PT requirements under CLIA by being classified as waived test
systems or devices.
A CLIA Waived test
is categorized as a 'simple laboratory examination or procedure that has an insignificant risk of an erroneous result,' meaning the tests can be performed by untrained users at point-of-care (POC) locations across the country.
Along with the growing availability of waived test
systems comes the reduction in quality and regulatory oversight.
In response to these concerns, many manufacturers have developed or refined testing devices to meet the CLIA criteria to be approved as waived test
ABMC is currently the only company offering a CLIA waived test
The FDA determined that the Nova StatStrip Glucose Hospital Meter System is simple to use and has a low risk for false results, and granted with the clearance waived test
system status under CLIA.
Moreover, the December 19 letter notes that a final rule on waived test
criteria has not been established and published.
Before running a waived test
, a CLIA Certificate of Waiver must be obtained from the Centers for Medicare & Medicaid Services (CMS).
We can now provide the General Chemistry 13 panel, which is a comprehensive screening panel, the General Chemistry 6 panel, the Liver Panel Plus, the Lipids Panel and the Lipids Plus Panel, as CLIA waived test
panels to the medical market.
Food and Drug Administration (FDA) as a waived test
under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.