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Quotient Reports Commencement Of Review Process Of Expanded Immunohematology Technical File Dossier By European Notified Body


Benzinga | Oct 1, 2021 06:02AM EDT

Quotient Reports Commencement Of Review Process Of Expanded Immunohematology Technical File Dossier By European Notified Body

Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), today announced the launch of the review process of the Expanded Immunohematology (IH) technical file dossier for review by the European notified body. The Company submitted part I of the dossier in September as planned.

"As a result of the hard work by our team, we are very pleased to have submitted the beginning of the technical file dossier for our Expanded IH microarray. As communicated, we progressed as planned and look forward to providing further updates at the next earnings call," said Manuel O. M?ndez, Chief Executive Officer of Quotient.

Instrument performance regarding time to result, intuitiveness, and technical service support, continues to prove impressive to customers conducting European field trials. The Company anticipates CE Mark approval around year-end, followed by the commercial launch in the EU and other countries which accept a CE mark.






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