FDA grants molecular test for intestinal bacteria 510(k) clearance — 3 insights

The FDA awarded Becton, Dickinson and Company's BD Max's extended enteric bacterial panel 510(k) clearance.

Here's what you should know:

1. BD Max is a molecular test which can detect intestinal bacteria that causes infectious diarrhea.

2. The test detects the majority of pathogens which cause acute gastroenteritis.

3. The extended enteric bacterial panel joins the enteric bacterial panel and the enteric parasite panel in the BD Max suite of offerings.