Irradiator, Blood to Prevent Graft Versus Host Disease
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Shandong. 1 is a contract manufacturer.
- RAD Source(China) Medical Technologies Company Limited Shandong, contract manufacturer
What Is FDA Product Code MOT?
Irradiator, Blood To Prevent Graft Versus Host Disease is FDA product code MOT, unclassified.
What Does It Take to Sell It in the United States?
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.
What Has Gone Wrong With It?
The FDA has recorded 2 recalls under this product code since 2002. None was by a company in China. The root cause the FDA records most often is Radiation Control for Health and Safety Act (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.