Food and Drug Administration confirms extra appeal for Roche cobas Zika virus Analysis

Roche deployed the cobas® Zika Analysis in April of 2016 under the Food and Drug Administration's IND Protocol to Monitor blood donations gathered in Puerto Rico. The cobas® Zika Analysis received commercial consent from the Food and Drug Administration in October of 2017, enabling routine Utilize of the cobas® Zika Analysis to backing individual donor screening efforts throughout Puerto Rico the continental U.S.. About the cobas Zika testManufactured by Roche, the cobas Zika Analysis for Utilize by the cobas® 6800/8800 Systems & cobas® Synergy software, is a qualitative in vitro nucleic acid screening Analysis for the direct revelation of Zika RNA in plasma specimens from individual human blood donors. The cobas® Zika Analysis is the newest addition to the Analyzing menu for the cobas® 6800/8800 Systems in the America market. Together by the cobas® 6800/8800 Systems, the cobas® Zika Analysis provides resolution for blood services to announce Zika & ensure which potentially infective blood units aren't made obtainable for transfusion.


Food and Drug Administration confirms extra appeal for Roche Zika virus Analysis

N.Y. (GenomeWeb) – Roche said today which the America FDA has confirmed an extra appeal for its Cobas Zika virus Analysis for Utilize on the Cobas 6800 & 8800 systems which enables streamlined screening of multiple individual blood or plasma donations which have been pooled together.

FDA Approves Additional Claim for Roche Zika Test

Food and Drug Administration Okays extra appeal For Roche Cobas Zika virus Analysis

according to Shutterstock picture(RTTNews.com) - Roche ( RHHBY ) said which the U.S. FDA confirms an extra appeal for the cobas Zika virus Analysis for Utilize on the cobas 6800/8800 Systems. The newly confirmed appeal allows for the streamlined screening of multiple individual blood or plasma donations which have been pooled together. In addition to supporting the generality recent BPAC recommendations, the expanded appeals for cobas Zika virus facilitate a simplified Analyzing workflow for blood screening laboratories Using the cobas 6800/8800 Systems by the cobas®Synergy software solution in the U.S.. Roche deployed the cobas Zika virus Analysis in April of 2016 under the FDA's IND Protocol to Monitor blood donations gathered in Puerto Rico. The cobas Zika virus Analysis received commercial consent from the FDA in October of 2017, enabling routine Utilize of the cobas Zika virus Analysis to backing individual donor screening efforts throughout Puerto Rico the continental U.S..






collected by :Lucy William
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