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FDA issues EUA for Yale’s SalivaDirect

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Yale intends to provide SalivaDirect to interested laboratories as an open source protocol, meaning that designated laboratories could follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions for use. Because this test does not rely on proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity laboratories, provided the labs comply with the conditions of authorization in the EUA.

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