OYG

St2 Assay

Product code

OYG

Device name

St2 Assay

Device class

Class 2

21 CFR

21 CFR 862.1117

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.

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