SCX

Immunoassay For Host Biomarkers Of Sepsis

Product code

SCX

Device name

Immunoassay For Host Biomarkers Of Sepsis

Device class

Class 2

21 CFR

21 CFR 866.3215

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

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

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-09-25.

1 summaries are archived here for direct download.