C. Difficile Nucleic Acid Amplification Test Assay
FDA product code OMN · Class I (low risk) · 21 CFR 866.2660 · Microbiology
In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.
4510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113433 | Simplexa C. Difficile Universal DirectOMN · Traditional | Focus Diagnostics, Inc. | 04/04/2012SE |
| K110203 | Xpert C. Difficle/Epi AssayOMN · Traditional | Cepheid | 04/07/2011SE |
| K110012 | Illumigene C. Difficile, and ILLUMIPRO-10OMN · Traditional | Meridian Bioscience, Inc. | 02/24/2011SE |
| K100818 | Illumigene C. Difficile, ILLUMIPRO-10 and Illumigene C. Difficile External Control Kit…OMN · Traditional | Meridian Bioscience, Inc. | 07/09/2010SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0568-2026 Class II | Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid…The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for… | Meridian Bioscience Inc | 10/07/2025Open, Classified |
| Z-1941-2014 Class II | illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10…Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of… | Meridian Bioscience Inc | 04/22/2014Terminated |