Blue Earth, MN (PRWEB) June 19, 2013
Express Diagnostics Int’l, Inc., manufacturer of DrugCheck® on-site drugs of abuse tests, today announced that it has received Class III medical device license approval from Health Canada to market and sell its DrugCheck® NxStep Onsite Drug Screen Cup in Canada. Class III licensure allows use of the rapid screening device in near-patient settings, such as physicians’ offices.
The DrugCheck NxStep Onsite Drug Screen Cup received Health Canada Class III approval for 24 different drugs and detection levels, or cutoffs. In addition to tests typically included in drugs of abuse urine screens, such as amphetamine, cocaine, opiates, and marijuana, the Drug Screen Cup is also approved to screen for drugs not often cleared for Health Canada Class III, including cotinine (nicotine), EDDP, K2/spice (synthetic marijuana), ketamine, and alcohol.
“We are very pleased to receive Health Canada Class III licensure for our NxStep Onsite Drug Screen Cup,” says Paul Johnson, CEO of Express Diagnostics. “Canada Class III approval will allow for wider distribution of our U.S.-made DrugCheck product, but more importantly, the expansive list of drugs and cutoffs approved for use in our Drug Screen Cup will deliver greater testing flexibility to administrators and healthcare providers throughout Canada to help improve screening and treatment for employees and patients nationwide.”
While the DrugCheck NxStep Onsite Drug Screen Cup is now Health Canada Class III approved in Canada, the device has been FDA 510(k) cleared-to-market for 17 drugs and detection levels (cutoffs) in the U.S. for several years. FDA 510(k) clearance allows the NxStep Onsite Drug Screen Cup to be used in the U.S. for pre-employment, random, and reasonable cause screening, as wel
Copyright©2012 Vocus, Inc.
All rights reserved