Antigens, Ha, Treponema Pallidum
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Guangdong. 1 is a contract manufacturer.
- Zhuhai Livzon Diagnostics Inc. Guangdong, contract manufacturer
How Is GMT Classified?
Antigens, Ha, Treponema Pallidum is FDA product code GMT, Class 2, 21 CFR 866.3830.
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. The review can be done by an FDA-accredited third party, which is usually faster. 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.