Hardy Diagnostics is a U.S. microbiology diagnostics and culture media company based in Santa Maria, California. Founded in 1980, it has grown into a large employee-owned enterprise serving clinical and laboratory markets.
The FDA granted Breakthrough Device Designations to NG-TEST® Candida auris and NG-TEST® Acineto-5®, two rapid assays targeting critical drug-resistant pathogens. Both tests deliver results within 15 minutes and are currently available for Research Use Only while FDA review continues.
The FDA has granted breakthrough device designation to two rapid diagnostic assays from NG Biotech and Hardy Diagnostics targeting Candida auris and carbapenem-resistant Acinetobacter baumannii, both identified as global health priorities by the WHO.
