Panels › Microbiology › Product code OZZ · Class 2

Bordetella Pertussis Dna Assay System

Regulation 866.3980

1510(k)s in 12 months (9 all time)

0recalls in 12 months (2 all time)

2recalls that name a 510(k)

Top companies in OZZ

Company	510(k)s	Recalls
Diasorin Molecular, LLC	2	0
Luminex Corporation	1	1
Meridian Bioscience, Inc.	2	0
Quidel Corporation	2	0
Great Basin Scientific, Inc.	1	0
Ortho-Clinical Diagnostics, Inc.	0	1
Roche Molecular Systems, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Jun 11, 2025	Ortho-Clinical Diagnostics, Inc. Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains material Open, Classified	OZZ	K181029
Aug 15, 2019	Luminex Corporation Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452 Open, Classified	OZZ	K163626

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