510(k) for HDC's Helicobacter pylori test:
This article was originally published in Clinica
HDC has received US FDA clearance to market its Entero-Test for detecting helicobacter pylori. The device uses a string absorption configuration to obtain active organisms from the stomach. Once the bacteria is retrieved, diagnosis can be carried out using any commercially available methods. According to the company of San Jose, California, the Entero-Test is the only procedure besides endoscopy which can provide the live bacteria for testing of antimicrobial susceptibility.