What approvals does the T-SPOT.TB test have?
The T-SPOT.TB test received approval from the US Food and Drug Administration (FDA) on July 30, 2008. The T-SPOT. TB test carries the CE mark which allows it to be legally placed on the market to be sold freely in the EU. Approvals have already been achieved in a number of territories outside the EU and approval is being sought in the remaining territories of commercial interest to the company.