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FDA Clearances

Stay current on TREK's latest FDA cleared products.

FDA Cleared
The VersaTREK Automated Microbial Detection System is FDA cleared.
VersaTREK® EZ Draw® is the only FDA-cleared, controlled, true, direct measured draw bottle on the market.
The VersaTREK Myco Susceptibility Kit consists of three primary antituberculosis drugs (FDA-cleared since 1999) – Rifampin (1 µg/ml), Isoniazid (0.4 µg/ml and 0.1 µg/ml), and Ethambutol (8 µg/ml and 5 ug/ml).
To complement and complete the VersaTREK System’s full line of primary Mycobacterium tuberculosis antimicrobials, Pyrazinamide (PZA) is also FDA-cleared.

The Vizion® Instrument is FDA cleared.

The Sensititre AIM System is FDA-cleared.

Click here to view the Sensititre standard formularies list (non-US)

Click here to view the Sensititre standard formularies list (US-only)

These lists are to be used For Information Only, and may be updated at any time by Thermo Fisher Scientific. Contact your Thermo Scientific Consumable Sales Specialist to obtain the most current list.


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