FDA Clearance for New illumigene™ C.difficile Pediatric Claim
go back to news archives A new pediatric claim for the illumigeneC. difficile molecular amplification test from Meridian Bioscience has received FDA clearance. The illumigenemolecular test is designed to target the region of the C. difficile DNA that is presented in all toxin A and/or toxin B producing strains. The illumigene test provides highly accurate results in under an hour. Meridian Bioscience's illumigenetest is the only C. difficile test that is cleared by the FDA for use on children under the age of two. Recent epidemiological data have indicated that the rate of community associated pediatric C. difficile increased by more than seventy percent from 1997 through 2006, which in turn is leading to increased hospitalizations among children. Rapid and accurate detection of C. difficile is critical in determining proper patient treatment. Meridian's new illumigeneC. difficile test provides a high level of sensitivity, with a simple workflow requiring less than two minutes of hands-on time per sample. The Company's illumigeneC. difficile test is available world-wide and its performance and customer acceptance has been very positive. |
NOTE: This item is from our 'historic' database and
may contain information which is not up to date.
Source : Meridian Bioscience, Inc. View Company Information
Posted on March 8, 2011
LATEST MICROBIOLOGY NEWS
MICROBIOLOGY EVENTS
-
Getting Equipped for the Future with the New MAS-100 Sirius® Microbial Air Sampler
1 Jul 2025 -
AI for Food Safety Professionals
8 Jul 2025 -
FEMS Micro
14 Jul 2025 -
Unmasking Endotoxins: A Sample Preparation Strategy to Overcome LER
15 Jul 2025 -
IAFP 2025
27 Jul 2025 -
ADLM 2025
27 Jul 2025 -
Food Safety Culture Workshop
9 Sep 2025 -
CPD accredited course: Level 3 HACCP & Food Safety
15 Sep 2025 -
Culture Eats HACCP for Breakfast (free)
On-demand Webinar -
A3P International Congress 2025
7 Oct 2025