bioMérieux, FDA autorizza test SPOTFIRE per la vaginite
- bioMérieux ottiene l’autorizzazione FDA 510(k) e la deroga CLIA per il test BIOFIRE SPOTFIRE Vaginitis Panel.
- Il test identifica otto cause di vaginite in circa 20 minuti direttamente sul luogo di cura.
- Commercializzazione negli Stati Uniti prevista all’inizio del 2027, seguita da un’espansione internazionale graduale.
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