Product code MCB
- Device name
- Antigen, C. Difficile
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132010 | VIDAS C DIFFICILE GDH | Biomerieux S.A. | 2013-10-09 |
| K112048 | IMMUNOCARD C. DIFFICILE GDH | Meridian Bioscience, Inc. | 2011-12-16 |
| K110620 | PREMIER C. DIFFICILE GDH | Meridian Bioscience, Inc. | 2011-05-03 |
| K053572 | C. DIFF QUIK CHEK | Techlab, Inc. | 2006-04-26 |
| K974881 | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A | Biosite Incorporated | 1998-03-20 |
| K955067 | CLEARVIEW C. DIFF A | Unipath , Ltd. | 1996-09-13 |
| K924062 | MERITEC C. DIFFICILE CONTROLS | Meridian Diagnostics, Inc. | 1992-10-19 |
| K904329 | CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1991-03-12 |
| K895915 | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM | Meridian Diagnostics, Inc. | 1990-03-12 |
| K833447 | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- | Bartels Immunodiagnostic Supplies, Inc. | 1984-05-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033891322748 | CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH | DIESSE DIAGNOSTICA SENESE SPA | 2025-08-19 |
| 00840733101687 | PREMIER C. difficile GDH | MERIDIAN BIOSCIENCE, INC. | 2020-09-21 |
| 00840733101793 | ImmunoCard C. difficile GDH | MERIDIAN BIOSCIENCE, INC. | 2020-08-11 |
| 03573026444204 | VIDAS® C. difficile GDH | BIOMERIEUX SA | 2019-11-19 |
| 00857031002141 | C. DIFF QUIK CHEK | TECHLAB, INC. | 2018-09-28 |
| 05391516747936 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| 05391516747998 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| 05391516748841 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| 05391516748858 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| 05391516747950 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 05391516748797 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 05391516748803 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |