Acon Laboratories, Inc.

CLIA waiver received for drugs of abuse tests

Published in Lab Law Weekly, November 11th, 2005

Acon Laboratories, Inc., recently received Clinical Laboratory Improvement Amendments (CLIA) waived status for its patent pending E-Z Split Key Cup and its multi-line drugs of abuse device tests.

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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Source: Lab Law Weekly (2005-11-11)

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