MCB · Class I · 21 CFR 866.2660

FDA Product Code MCB: Antigen, C. Difficile

Leading manufacturers include Meridian Bioscience, Inc., Meridian Diagnostics, Inc. and Techlab, Inc..

10
Total
10
Cleared
145d
Avg days
1984
Since

FDA 510(k) Cleared Antigen, C. Difficile Devices (Product Code MCB)

10 devices
1–10 of 10
Cleared Oct 09, 2013
VIDAS C DIFFICILE GDH
K132010
Biomerieux S.A.
Microbiology · 100d
Cleared Dec 16, 2011
IMMUNOCARD C. DIFFICILE GDH
K112048
Meridian Bioscience, Inc.
Microbiology · 151d
Cleared May 03, 2011
PREMIER C. DIFFICILE GDH
K110620
Meridian Bioscience, Inc.
Microbiology · 61d
Cleared Apr 26, 2006
C. DIFF QUIK CHEK
K053572
Techlab, Inc.
Microbiology · 125d
Cleared Mar 20, 1998
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
K974881
Biosite Incorporated
Microbiology · 80d
Cleared Sep 13, 1996
CLEARVIEW C. DIFF A
K955067
Unipath , Ltd.
Microbiology · 312d
Cleared Oct 19, 1992
MERITEC C. DIFFICILE CONTROLS
K924062
Meridian Diagnostics, Inc.
Microbiology · 68d
Cleared Mar 12, 1991
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY
K904329
Baxter Healthcare Corp
Microbiology · 173d
Cleared Mar 12, 1990
MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM
K895915
Meridian Diagnostics, Inc.
Microbiology · 153d
Cleared May 21, 1984
CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-
K833447
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 229d

About Product Code MCB - Regulatory Context