Chlamydophila Pneumoniae Dna Assay System
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong. 1 is a contract manufacturer.
- Hochuen Medical Technology Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
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.
How Is OZY Classified?
Chlamydophila Pneumoniae Dna Assay System is FDA product code OZY, Class 2, 21 CFR 866.3980.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.