The waiver applies to all 14 drugs that the company currently tests for in addition to two different cut-off levels for its opiate and cocaine tests.
Clinical Laboratory Improvement Amendments (CLIA) waived tests are recognized by the FDA to be so simple to use and so accurate that there is little risk of error.
Stan Cipkowski, CEO of American Bio Medica (ABMC), said: “The granting of the CLIA waiver is expected to greatly impact our relationship with our laboratory alliance as up until this point, the lab alliance has been obtaining CLIA waived devices from another supplier. Now that our Rapid Tox device is CLIA waived, they will be obtaining all of their urine based point of collection devices from ABMC.”