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510(k) K192046

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set by DiaSorin, Inc. — Product Code QFO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 28, 2019
Date Received: July 31, 2019
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Zika Virus Serological Reagents
Device Class: Class II
Regulation Number: 866.3935
Review Panel: MI
Submission Type

Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.

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510(k) K192046

Clearance Details

Device Classification

Other clearances by DiaSorin, Inc.

Other clearances for product code QFO