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510(k) K181029

Solana Bordetella Complete Assay by Quidel Corporation — Product Code OZZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2018
Date Received
April 18, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bordetella Pertussis Dna Assay System
Device Class
Class II
Regulation Number
866.3980
Review Panel
MI
Submission Type

A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

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