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FDA approves emergency use of a test for A(H1N1) influenza


ROCKVILLE, Md. The Food and Drug Administration has authorized emergency use of a test for the A(H1N1) flu virus.

The FDA announced Friday that it had issued an emergency use authorization to Focus Diagnostics’ H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction diagnostic test, the third test to be granted EUA since the virus emerged in April.

The EUA allows the company to distribute the test to laboratories certified under the Clinical Laboratory Improvement Amendments to perform high-complexity tests, though the test is not typically used in a doctor’s office because of its complexity.

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