October 2025—The FDA has cleared Hardy Diagnostics’ NG-Test CTX-M Multi, an in vitro diagnostic immunoassay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of extended-spectrum beta-lactamase production. These enzymes confer resistance to many beta-lactam antibiotics, making infections more difficult to treat. The test delivers results in 15 minutes.
Hardy Diagnostics, 800-266-2222