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How is HPV testing regulated in the EU?

EU HPV regulated Testing
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How is HPV testing regulated in the EU?

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PreTect HPV-Proofer is a diagnostic test designed, developed and produced according to the EU in vitro diagnostic directive (98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices). PreTect HPV-Proofer is CE marked since May 2003. No HPV tests can be sold in EU without complying with these regulations.

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