FDA 510(k) Clearance of NOW® Influenza A & B Rapid Test
Binax, Inc., a leading developer of rapid diagnostic tests, have announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the NOW® Influenza A & B test. This latest test from Binax replaces two individual tests, NOW Flu A and NOW Flu B, and complements the companys portfolio of diagnostic tests for respiratory tract infections.
NOW Influenza A & B is an easy, one-step test that is as simple to read as a pregnancy test with results available in 15 minutes. Performance is comparable to NOW Flu A and NOW Flu B tests currently on the market. The advantage of the new test is the ability to identify both flu A and flu B and differentiate between the two using one simple device.
Source : Binax, Inc. [USA]
Now part of Alere, Inc View Company Information
Posted on November 1, 2004