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Home » Longhorn Vaccines and Diagnostics’ PrimeStore Cleared by FDA
Longhorn Vaccines and Diagnostics’ PrimeStore Cleared by FDA
![ClearanceStamp_Gray.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Gray.gif?t=1576043982&width=430)
March 22, 2018
The FDA granted 510(k) clearance for Longhorn Vaccine’s PrimeStore molecular transport medium, designed to inactivate pathogens and stabilize RNA and DNA for downstream molecular testing and characterization.
PrimeStore is used for stabilization, transportation and inactivation of infectious unprocessed nasal washes thought to contain influenza A virus RNA. It is also intended to do the same for infectious unprocessed sputum samples thought to contain Mycobacterium tuberculosis DNA from human samples.
The molecular transport device can accelerate efforts to identify and control seasonal, pandemic and endemic diseases like influenza and M. tuberculosis.
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