Antigen, C. Difficile
FDA product code MCB · Class I (low risk) · 21 CFR 866.2660 · Microbiology
10510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132010 | Vidas C Difficile GDHMCB · Traditional | Biomerieux S.A. | 10/09/2013SE |
| K112048 | Immunocard C. Difficile GDHMCB · Traditional | Meridian Bioscience, Inc. | 12/16/2011SE |
| K110620 | Premier C. Difficile GDHMCB · Traditional | Meridian Bioscience, Inc. | 05/03/2011SE |
| K053572 | C. Diff Quik ChekMCB · Traditional | Techlab, Inc. | 04/26/2006SE |
| K974881 | Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin aMCB · Traditional | Biosite Incorporated | 03/20/1998SE |
| K955067 | Clearview C. Diff aMCB · Traditional | Unipath , Ltd. | 09/13/1996SE |
| K924062 | Meritec C. Difficile ControlsMCB · Traditional | Meridian Diagnostics, Inc. | 10/19/1992SE |
| K904329 | Clostridium Difficile Toxin a Enzyme ImmunoassayMCB · Traditional | Baxter Healthcare Corp | 03/12/1991SE |
| K895915 | Meritec(Tm) - C. Difficile Latex Test SystemMCB · Traditional | Meridian Diagnostics, Inc. | 03/12/1990SE |
| K833447 | Cytotoxicity Assay for Clostridium-MCB · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 05/21/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0426-2022 Class II | VIDAS Clostridium Difficile GDH, REF 30125-01bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… | bioMerieux, Inc. | 09/22/2021Open, Classified |
| Z-1352-2008 | Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE…False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual… | Biosite Inc | 12/04/2007Terminated |