www.fdanews.com/articles/69057-chembio-submits-two-hiv-rapid-tests-to-the-fda-for-pma
Chembio Submits Two HIV Rapid Tests to the FDA for PMA
February 22, 2005
Chembio Diagnostics announced that it submitted an application to the FDA for premarket approval (PMA) of its Sure Check HIV and HIV Stat-Pak rapid HIV tests. Both Sure Check HIV and HIV Stat-Pak are rapid test devices that can detect antibodies to the HIV virus within 15 minutes using finger stick whole blood samples.
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