ClearanceBrief
Panels › Microbiology › Product code PSZ · Class 2

Devices Detecting Influenza A, B, And C Virus Antigens

Regulation 866.3328

2510(k)s in 12 months (73 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
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Top companies in PSZ

Company510(k)sRecalls
Becton, Dickinson and Co.120
Quidel Corp.82
Becton, Dickinson & CO63
Binax, Inc.60
Meridian Bioscience, Inc.40
Princeton BioMeditech Corp.40
Sa Scientific, Inc.40
Alere Scarborough, Inc.30
Bd30
Genzyme Corp.30
DateFirm and productCodeLinked 510(k)
Feb 9, 2022Becton Dickinson & Co.
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
Open, Classified		 PSZK180438
Sep 25, 2020Quidel Corporation
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Terminated		 PSZNone listed
Apr 3, 2019Becton Dickinson & Co.
BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
Terminated		 PSZK112277
Apr 3, 2019Becton Dickinson & Co.
BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
Terminated		 PSZK180438
Dec 15, 2017Quidel Corporation
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and
Terminated		 PSZK162438
K162911

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