Recently, the FDA sent a letter to manufacturers of blood glucose monitoring systems (BGMS) that are currently under FDA review for a 510(k) submission asking them to provide validated cleaning and disinfecting procedures for the exterior surfaces of these devices. Specifically, these manufacturers are required to demonstrate that their disinfection protocol is effective against the bloodborne pathogen Hepatitis B virus. If this is testing that you need, ATS Labs has the expertise to help you!
ATS Labs has worked very closely with the FDA to develop a protocol for verifying the inactivation of a Hepatitis B virus surrogate on BGMS surfaces. We are pleased to provide testing services that validate the disinfectant products recommended for use on your BGMS are effective against Hepatitis B virus. If you would like more information about this testing, please contact Karen Ramm at 651-379-5518 or karen.ramm@ats-labs.com.
In addition, we can test a wide variety of other viruses that may be needed to satisfy other FDA requirements for other medical devices. Please contact us to discuss our other viral testing services.