Bordetella Pertussis Dna Assay System
- US Product Code (FDA)
- OZZView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.3980View CFR Regulation →
- Medical specialty
- Microbiology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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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Bordetella Pertussis Dna Assay System is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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