Meridian Granted Special 510(k) Clearance To Add 2009 H1N1 Influenza A Virus Analytical Sensitivity Claim To The TRU FLU(R) Test Package Insert

Main Category: Swine Flu
Also Included In: Flu / Cold / SARS
Article Date: 20 Sep 2009 - 0:00 PDT


Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) announced that the company has been granted a Special 510(k) clearance to update the TRU FLU package insert to include analytical sensitivity claims with two strains of 2009 H1N1 virus cultured from positive respiratory specimens. TRU FLU is a rapid test which identifies influenza A and B in human specimens.

Meridian's TRU FLU and TRU RSV® products are unique in that they feature a closed test system that allows a specimen to be contained within the device once it has been inserted. While the performance characteristics of the device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established, the analytical sensitivity claims with the two strains adds an additional important product benefit.

John A. Kraeutler, Chief Executive Officer, commented, "Meridian is working diligently to provide our global customers who are facing an influenza pandemic with product features that will assist them from a testing standpoint. We must provide our customers with tools that allow them to do their jobs in a rapid, safe and effective manner, thus improving patient care."

Source
Meridian Bioscience, Inc.

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