C. Difficile Nucleic Acid Amplification Test Assay
Microbiology · 21 CFR 866.2660
In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Meridian Bioscience IncOpen, ClassifiedNov 19, 2025
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Z-0568-2026 · View FDA record ↗ - Meridian Bioscience IncTerminatedJun 27, 2014
illumipro-10 Incubator/Reader, Meridian Bioscience, Inc.
Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.
Z-1941-2014 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Great Basin ScientificApr 30, 2012
DEN120013 · PORTRAIT ANALYZER
- Focus Diagnostics, Inc.Apr 4, 2012
K113433 · SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
- CepheidApr 7, 2011
K110203 · XPERT C. DIFFICLE/EPI ASSAY
- Meridian Bioscience, Inc.Feb 24, 2011
K110012 · ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
- Meridian Bioscience, Inc.Jul 9, 2010
K100818 · ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920