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Quotient Limited Provides Status Update on the Initial SDS Microarray and MosaiQ Instrument for .
Quotient LimitedDecember 10, 2020 GMT
JERSEY, Channel Islands, Dec. 10, 2020 (GLOBE NEWSWIRE) Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), today announced that it received a request from the U.S. Food and Drug Administration (FDA) for additional testing data regarding the 510(k) application for the Initial Serological Disease Screening Microarray (SDS) and MosaiQ instrument. The data the FDA has requested relates to specific individual performance characteristics of the assays on the microarray. In response to this request, the Company intends to re-submit its application, with the additional data requested by the FDA, in early 2021. Following that submission, the Company is targeting to receive the FDA 510(k) clearance in mid-2021. ....

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