Published in Lab Law Weekly, November 11th, 2005
Both products, which have been 510(k)-cleared by the U.S. Food and Drug Administration (FDA), are simple enough to be used by non-laboratory trained personnel. CLIA waived tests are the most widely used tests in physician's office laboratories and are in-demand for occupational health and criminal justice applications.
Acon's proprietary E-Z Split Key Cup, designed to virtually eliminate exposure to urine, has a 24-month shelf life at room temperature....
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