
Longhorn Vaccines and Diagnostics, LLC
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PrimeStore MTM is an FDA 510(k)-cleared medical device (DEN170029) manufactured by Longhorn Vaccines and Diagnostics, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 18, 2018. Regulation: 8.