PFQ

Mmp-9 Test System

Product code

PFQ

Device name

Mmp-9 Test System

Device class

Class 1

21 CFR

21 CFR 862.1540

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).