Poway, CA, August 11, 2016 --(PR.com
)-- Alfa Scientific Designs, a leader in the development and manufacture of rapid immunoassay point-of-care tests, announced today that the U.S. Food and Drug Administration (FDA) has granted OTC/CLIA waived status to its buprenorphine (BUP) drug test.
“We are dedicated to provide this important test to a larger market segment in our efforts to help fight an epidemic in opioid drug addiction," said Chai Bunygidj, Ph.D., General Manager and COO.
This waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.Alfa Scientific Designs
(ALFA) is one of very few companies to successfully apply and be granted CLIA-waived approval by the U.S. FDA. With the BUP drug test now OTC/CLIA-waived, it makes a total of 15 drug tests that are now OTC/CLIA-waived for ALFA.
For more information, visit www.alfascientific.com.
About Alfa Scientific Designs:
Celebrating its 20th anniversary in 2016, Alfa Scientific Designs is a leader in the development and manufacturing of rapid immunoassay point-of-care tests. It offers a broad range of services, including contract product development, technology transfer, OEM services, custom assembly, and packaging with private labeling, all performed in the U.S.A. Established in 1996, ALFA develops breakthrough designs produced to the highest quality standards. The ALFA Product line is U.S. FDA Regulated and ISO Certified. For more information, visit www.alfascientific.com.