QCH

Assayed Quality Control Material For Clinical Microbiology Assays

Product code

QCH

Device name

Assayed Quality Control Material For Clinical Microbiology Assays

Device class

Class 2

21 CFR

21 CFR 866.3920

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

Serologic controls for microbiology assays

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: 2025-12-30.

1 summaries are archived here for direct download.