Quest Diagnostics Receives First FDA Clearance for H1N1 MDx Test | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today announced that Quest Diagnostics' Simplexa Influenza A H1N1 test has received 510(k) clearance, making it the first test to receive clearance from the agency for the virus.

As a result, the test will be the only one allowed to be marketed in the US after late June.

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