FDA 510k Clearance and ISO Certified Shipping and Storage Facility

FDA 510k Clearance and ISO Certified Shipping and Storage Facility


Drug Testing Ace Stores and ships from FDA 510K cleared and ISO 13485:2003+AC:2007 Certified Facility.

FDA 510K Clearance: FDA 510k Clearance for a Storage and Shipping Facility is a legal protection which means that the facility does not alter the original test´s packaging in any way. This means that they do not open drug testing kit packaging in order to distribute individual tests to customers which could be construed as tampering by the facility. Furthermore, our storage and shipping facility maintains strict temperature control standards so that drug testing kits are not kept in an overheated environment which could impact the validity of the tests. This not only ensures that you are sure to receive our drug and alcohol testing kits in the original unaltered condition from the manufacturer, but it also ensures that the testing kits and supplies are stored and shipped in a manner that will not invalidate test results.

If you are buying drug and alcohol testing kits from facilities that are NOT FDA 510k Cleared, then it is possible that the products could have been compromised which would increase your exposure in a legal action against your company. In addition, many of our competitors sell individual tests from open boxes, mixed product lots, old inventory, and possibly returns.

We take great care in ensuring that you receive only boxed drug and alcohol testing kits and supplies that were packaged by the manufacturer, stored in a temperature controlled facility and shipped to you in safe packaging that meets or exceeds the manufacturer’s guidelines.

ISO Certification: Our ISO Certification is for our quality management system, specifically developed for the handling of our drug testing kits.

Our certification is ISO 13485:2003+AC:2007 http://tuvamerica.com/services/qmservices/iso13485.cfm