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C. Difficile Nucleic Acid Amplification Test Assay
FDA product code OMN · Class 1 · Microbiology
8
Registered devices
0
Adverse events
2
Recalls
5
510(k) clearances
Devices with this code
Alethia™ C. difficile — MERIDIAN BIOSCIENCE, INC.Simplexa™ C. difficile Universal Direct — DIASORIN MOLECULAR LLCAlethia™ C. difficile External Control Kit — MERIDIAN BIOSCIENCE, INC.illumigene C. difficile External Control Kit — MERIDIAN BIOSCIENCE, INC.Xpert C. difficile/Epi — CEPHEIDXpert C. difficile/Epi — CEPHEIDPortrait Toxigenic C. difficile Assay — GREAT BASIN SCIENTIFIC, INC.illumigene C. difficile — MERIDIAN BIOSCIENCE, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-07 | Meridian Bioscience Inc | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. |
| 2014-04-22 | Meridian Bioscience Inc | Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration. |
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