Product code MCB— Microbiology

FDA has cleared 10 devices under product code MCB between 1984 and 2013, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20131 clearance
• 20112 clearances
• 20061 clearance
• 19981 clearance
• 19961 clearance
• 19921 clearance
• 19911 clearance
• 19901 clearance
• 19841 clearance

• Meridian Diagnostics, Inc.2 clearances
• Meridian Bioscience, Inc.2 clearances
• Unipath , Ltd.1 clearance
• Techlab, Inc.1 clearance
• Biosite Incorporated1 clearance
• Biomerieux S.A.1 clearance
• Baxter Healthcare Corp1 clearance
• Bartels Immunodiagnostic Supplies, Inc.1 clearance

• K132010 — VIDAS C DIFFICILE GDHBiomerieux S.A.·2013-10-09
• K112048 — IMMUNOCARD C. DIFFICILE GDHMeridian Bioscience, Inc.·2011-12-16
• K110620 — PREMIER C. DIFFICILE GDHMeridian Bioscience, Inc.·2011-05-03
• K053572 — C. DIFF QUIK CHEKTechlab, Inc.·2006-04-26
• K974881 — TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN ABiosite Incorporated·1998-03-20
• K955067 — CLEARVIEW C. DIFF AUnipath , Ltd.·1996-09-13
• K924062 — MERITEC C. DIFFICILE CONTROLSMeridian Diagnostics, Inc.·1992-10-19
• K904329 — CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAYBaxter Healthcare Corp·1991-03-12
• K895915 — MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEMMeridian Diagnostics, Inc.·1990-03-12
• K833447 — CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-Bartels Immunodiagnostic Supplies, Inc.·1984-05-21