Antigen, C. Difficile
The Clostridium difficile antigen reagent is a microbiology diagnostic device used to detect C. difficile antigens in stool specimens, aiding in the diagnosis of C. difficile-associated diarrhea and colitis. It is classified as FDA Class I under 21 CFR 866.2660 within the Microbiology specialty, subject only to general controls. The product code is MCB and the device is not GMP-exempt, requiring basic quality system compliance. It is not implanted and does not sustain life.
Research product code MCB in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MCB
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K132010 | VIDAS C DIFFICILE GDH | Oct 09, 2013 | Substantially Equivalent | Biomerieux S.A. |
| K112048 | IMMUNOCARD C. DIFFICILE GDH | Dec 16, 2011 | Substantially Equivalent | Meridian Bioscience, Inc. |
| K110620 | PREMIER C. DIFFICILE GDH | May 03, 2011 | Substantially Equivalent | Meridian Bioscience, Inc. |
| K053572 | C. DIFF QUIK CHEK | Apr 26, 2006 | Substantially Equivalent | Techlab, Inc. |
| K974881 | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A | Mar 20, 1998 | Substantially Equivalent | Biosite Incorporated |
| K955067 | CLEARVIEW C. DIFF A | Sep 13, 1996 | Substantially Equivalent | Unipath , Ltd. |
| K924062 | MERITEC C. DIFFICILE CONTROLS | Oct 19, 1992 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K904329 | CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY | Mar 12, 1991 | Substantially Equivalent | Baxter Healthcare Corp |
| K895915 | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM | Mar 12, 1990 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K833447 | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- | May 21, 1984 | Substantially Equivalent | Bartels Immunodiagnostic Supplies, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.