Product Certification

Patent granted in major countries around the world (United States, China, European Union, Japan, Australia, India, Singapore)

IEC 61010 product safety certification and IEC 61326-2-6:2020 electromagnetic safety certification from TUV

FDA emergency authorization for COVID-19 RT-qPCR Assay on XDive

FDA emergency authorization for SalivaDirect™ COVID-19 Assay on XDive

FDA emergency authorization for MonkeyPox COVID-19 Assay on XDive

ISO13485 production facility, including IVD equipment, consumables, IVD reagents and IVD infectious disease diagnostic kits