K202755

Substantially Equivalent

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

Applicant: Diasorin Molecular, LLC
Product code: QDZ
Advisory panel: Microbiology
Date received: 2020-09-21
Decision date: 2022-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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