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Panels › Microbiology › Product code MCB · Class 1

Antigen, C. Difficile

Regulation 866.2660

0510(k)s in 12 months (10 all time)

0recalls in 12 months (4 all time)

3recalls that name a 510(k)

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Top companies in MCB

Company	510(k)s	Recalls
Meridian Bioscience, Inc.	2	2
Biomerieux S.A.	1	1
Biosite Incorporated	1	1
Meridian Diagnostics, Inc.	2	0
Bartels Immunodiagnostic Supplies, Inc.	1	0
Baxter Healthcare Corp	1	0
Techlab, Inc.	1	0
Unipath , Ltd.	1	0

Date	Firm and product	Code	Linked 510(k)
Sep 22, 2021	bioMerieux, Inc. VIDAS Clostridium Difficile GDH, REF 30125-01 Open, Classified	MCB	None listed
Mar 27, 2008	Biosite Inc Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121 Terminated	MCB	K974881
Jan 23, 2003	Meridian Bioscience Inc Premier brand Toxins A & B, diagnostic test kits, one kit per pouch, one pouch per shipping box. Terminated	MCB	K993914
Jan 23, 2003	Meridian Bioscience Inc Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box. Terminated	MCB	K926442

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