QPS

Immunoassay For Host Biomarkers Of Infection

Product code

QPS

Device name

Immunoassay For Host Biomarkers Of Infection

Device class

Class 2

21 CFR

21 CFR 866.3215

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.

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