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Antigen, C. Difficile
FDA product code MCB · Class 1 · Microbiology
12
Registered devices
9
Adverse events
4
Recalls
10
510(k) clearances
Devices with this code
Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.VIDAS® C. difficile GDH — BIOMERIEUX SACHORUS CLIA CLOSTRIDIUM DIFFICILE GDH — DIESSE DIAGNOSTICA SENESE SPAPREMIER C. difficile GDH — MERIDIAN BIOSCIENCE, INC.ImmunoCard C. difficile GDH — MERIDIAN BIOSCIENCE, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.C. DIFF QUIK CHEK — TECHLAB, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2007-12-04 | Biosite Inc | False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to |
| 2002-12-26 | Meridian Bioscience Inc | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. |
| 2002-12-26 | Meridian Bioscience Inc | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. |
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