Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.American Bio Medica, a biotechnology company, has announced that the FDA has granted CLIA waived status to the company's Rapid Tox point of collection drug test product line.
Subscribe to our email newsletter
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.”