FDA Product Code OZZ: Bordetella Pertussis Dna Assay System
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.
Leading manufacturers include Roche Molecular Systems, Inc..
List of Bordetella Pertussis Dna Assay System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Bordetella Pertussis Dna Assay System devices (product code OZZ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →