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What regulatory approvals does the T-SPOT.TB test have?

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What regulatory approvals does the T-SPOT.TB test have?

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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 marketed in the EU. Approvals have already been achieved in a number of territories outside the EU and approval is being sought in many other countries.

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