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510(k) K133673

ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA by Meridian Bioscience, Inc. — Product Code OZZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2014
Date Received
November 29, 2013
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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