Chlamydophila Pneumoniae Dna Assay System
The Chlamydophila Pneumoniae DNA Assay System is a qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens, aiding in the diagnosis of Chlamydophila pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients with signs and symptoms of upper respiratory tract infection. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OZY, with regulation number 866.3980 under the Microbiology medical specialty.
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Basic Information
- Product Code
- OZY
- Device Class
- FDA class 2
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.