Published in Medical Letter on the CDC and FDA, December 31st, 2006
The CLIA (Clinical Laboratory Improvement Act) waiver allows Chembio to market these HIV tests to a potential market of approximately 189,000 laboratory entities across the United States, including doctors' offices and clinics.
Larry Siebert, chief executive officer of Chembio, said, "CLIA Waiver is an important milestone, as this now allows us to submit final labeling changes to the FDA for marketing by Inverness Medical Innovations (IMA), our U.S. marketing partner for this product. These changes will be submitted during...
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