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..
FDA 510(k) Cleared Bordetella Pertussis Dna Assay System Devices (Product Code OZZ)
About Product Code OZZ - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code OZZ since 2014, with 9 receiving FDA clearance (average review time: 130 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OZZ have taken an average of 350 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.
OZZ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →