NEW YORK — Spectrum Solutions said on Wednesday that it has received CE marking for two SDNA saliva collection devices for molecular diagnostic testing.
With the CE mark, Spectrum's SDNA-2000 device can now be used with over-the-counter in-home testing kits, while the SDNA-3000 device can be used with prescription-only in vitro diagnostics, according to the Draper, Utah-based company.
In October, the US Food and Drug Administration granted Emergency Use Authorization for another collection device, Spectrum's SDNA-1000, for use with SARS-CoV-2 tests developed by DxTerity Diagnostics and Infinity Biologix, formerly RUCDR Infinite Biologics.