MCB · Antigen, C. Difficile
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | MCB |
|---|---|
| Device Name | Antigen, C. Difficile |
| Regulation | 21 CFR 866.2660 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132010 | VIDAS C DIFFICILE GDH | Biomerieux S.A. | Oct 9, 2013 | SESE |
| K112048 | IMMUNOCARD C. DIFFICILE GDH | Meridian Bioscience, Inc. | Dec 16, 2011 | SESE |
| K110620 | PREMIER C. DIFFICILE GDH | Meridian Bioscience, Inc. | May 3, 2011 | SESE |
| K053572 | C. DIFF QUIK CHEK | Techlab, Inc. | Apr 26, 2006 | SESE |
| K974881 | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A | Biosite Incorporated | Mar 20, 1998 | SESE |
| K955067 | CLEARVIEW C. DIFF A | Unipath , Ltd. | Sep 13, 1996 | SESE |
| K924062 | MERITEC C. DIFFICILE CONTROLS | Meridian Diagnostics, Inc. | Oct 19, 1992 | SESE |
| K904329 | CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY | Baxter Healthcare Corp | Mar 12, 1991 | SESE |
| K895915 | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM | Meridian Diagnostics, Inc. | Mar 12, 1990 | SESE |
| K833447 | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- | Bartels Immunodiagnostic Supplies, Inc. | May 21, 1984 | SESE |
Top Applicants
- Meridian Bioscience, Inc. — 2 clearances
- Meridian Diagnostics, Inc. — 2 clearances
- Bartels Immunodiagnostic Supplies, Inc. — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Biomerieux S.A. — 1 clearance
