PR.com: Business Directory, Press Releases, Jobs, Products, Services, Articles
 
Businesses Articles Press Releases Follow @PRcom
Press Release Pricing | News by Category | News by Country | News by US Region | Recent News | PR.com News on Your Site
 

Press Releases

 
Alfa Scientific Designs

Press Release

Share      Blog

Receive press releases from Alfa Scientific Designs: By Email PDF Version RSS Feeds:

Alfa Scientific Designs Granted OTC/CLIA Waived Status for BUP Drug Test by the Food and Drug Administration


Company now has a total of 15 drug tests that are OTC/CLIA-waived.

Alfa Scientific Designs Granted OTC/CLIA Waived Status for BUP Drug Test by the Food and Drug Administration
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.
Contact Information
Alfa Scientific Designs
Jeanette Christian - Marketing Communications
858-413-1276
Contact
www.alfascientific.com

Click here to view the list of recent Press Releases from Alfa Scientific Designs
Promote Your Business