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OB), the biopharmaceutical research and medical device company for early detection and treatment of reproductive-tract cancers, today announced that it has completed the process of demonstrating conformity of the e2 Collector[TM] cervical cell collection device to the requirements of the Medical Device Directive for sales into the European Union. Pamela Misajon, Vice President of Regulatory and Clinical Affairs stated, "The CE Mark is an indication that our company has met essential health, safety and performance protection requirements detailed in the European Medical Device Directive 93/42/EEC. In Europe, POC testing devices are regulated by the In-Vitro Medical Device Directive. |
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