NQD

Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Product code

NQD

Device name

Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Device class

Class 2

21 CFR

21 CFR 866.5270

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.

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

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-04-02.

2 summaries are archived here for direct download.