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FDA device approvals: BD Diagnostics get nod for bacterial gastroenteritis detection panel

10:00 am by | 0 Comments

M2PHARMA - BD Diagnostics, part of US medical technology company Becton, Dickinson and Co (NYSE:BDX), said Wednesday that its BD MAX Enteric Bacterial Panel had received US FDA authorisation for the detection of the most common causes of bacterial gastroenteritis.

The BD MAX Enteric Bacterial Panel, to be used on the BD MAX System, is a qualitative IVD test detecting DNA from Campylobacter spp. (jejuni and coli), Salmonella spp., Shigella spp./Enteroinvasive E. coli (EIEC), in addition to stx 1 and stx 2 genes in stool specimens.

The test can identify bacterial pathogens in compliance with widely recommended clinical testing algorithms for selecting diagnostic tests based on patient history and clinical presentation. The use of such focused panels make it possible to implement enteric molecular testing in a cost effective manner. Furthermore, the BD MAX Enteric Bacterial Panel enables laboratories to perform CDC recommended and Joint Commission required STEC screening.

BD Diagnostics has recently announced that its BD MAX Enteric Parasite Panel has obtained the CE mark for the qualitative detection of the parasitic enteric pathogens Giardia lamblia, Cryptosporidium spp. (C. hominis and C. parvum), and Entamoeba histolytica directly from stool specimens.

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