Flow Cytometric Reagents and Accessories.

What Is It?

To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.

How Is OYE Classified?

Flow Cytometric Reagents And Accessories. is FDA product code OYE, Class 2, 21 CFR 864.5220.

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. 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.

What Do the Recalls Say?

The FDA has recorded 26 recalls under this product code since 2014. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (7), Software design (2) and Material/Component Contamination (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.