K101529

Substantially Equivalent

BD DIRECTIGEN EZ FLU A+B ASSAY

Applicant: Becton, Dickinson & CO
Product code: PSZ
Advisory panel: Microbiology
Date received: 2010-06-02
Decision date: 2010-06-14
Decision: Substantially Equivalent
Clearance type: Special
Location: La Jolla, CA, US

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