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 by Our On Site Microbiologists
Patient safety relies on your Aseptic Technique and Enviornmental Control protocols. You can count on our quality culture media for your verification programs.
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 Newest 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>