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Hardy Diagnostics

About Us:

Hardy Diagnostics is a 100% employee-owned company, licensed by the FDA as an in vitro medical device manufacturer with an ISO 13485 certified quality management system.

We are Microbiology Experts ready to help you with regulatory compliance solutions.

Manufactured and Quality Tested On Our Premises

No one wants “positives”, but when patient safety relies on Personnel Aseptic Technique efficacy tests, and Environmental Control verification sample results, you can count on us for quality culture media.

Our full suite of Products for USP Regulatory Compliance includes:

A Complete line of Products to comply with USP <797>

  • Media-Fill Test Kits, or a la carte Components for Custom Media-Fill Simulation Designs
  • Culture Media Agar Plates and Swabs for Personnel and Surface Monitoring
  • The New Generation of Microbial Air Samplers
  • Culture Media Broths and Rinse Fluids in Septum Vials for Sterility Testing, per USP <71>
  • Technique and Spill Prevention Training Kit for USP <800>

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Compounding: Supplies, Equipment, Training