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Quotient Limited Announces Receipt of the ISO 13485:2016 Certification of its State of the Art MosaiQ™ Microarray Manufacturing Facility | ||
By: Nasdaq / GlobeNewswire - 11 Dec 2018 | Back to overview list |
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JERSEY, Channel Islands, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), today reported receipt of the formal ISO 13485:2016 certification for its state of the art MosaiQ™ multiplexing microarray manufacturing facility following the successful conclusion of the related European regulatory audit in September of this year. This manufacturing system approval is a critical step in the ongoing commercialization plans for the MosaiQ™ microarray technology which is designed to transform transfusion diagnostics and beyond. Following the recent CE marking of the MosaiQ™ instrument, this ISO certification represents the second of three critical approvals required for entry into the European transfusion diagnostics market. Following successful field trials earlier this year the Company also filed a CE mark submission for its initial Immunohematology (IH) microarray in September of 2018. Franz Walt, Quotient’s Chief Executive Officer commented, “As a result of this important milestone, all future microarray development can now benefit both from the instrument CE mark and from the medical device specific ISO 13485:2016 certification of our high-volume microarray manufacturing facility.” About Quotient Limited Forward-Looking Statements The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions. CONTACT: Christopher Lindop, Chief Financial Officer - chris.lindop@quotientbd.com +41 799 61 69 38 |
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Copyright 2018 Nasdaq / GlobeNewswire | Back to overview list |