OZY — Chlamydophila Pneumoniae Dna Assay System Class II
FDA product code OZY covers "Chlamydophila Pneumoniae Dna Assay System", a Class II medical device regulated under 21 CFR 866.3980. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- OZY
- Device Class
- Class II
- Regulation Number
- 866.3980
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens. Detection of Chlamydophila pneumoniae DNA aids in the diagnosis of Chlamydophila pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.