What Is This Device?
A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye.
How Is PFQ Classified?
Mmp-9 Test System is FDA product code PFQ, Class 1, 21 CFR 862.1540.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Do the Recalls Say?
The FDA has recorded 3 recalls under this product code since 2017. None was by a company in China. The root cause the FDA records most often is Process design (3).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.