OZN

C. Difficile Toxin Gene Amplification Assay

Product code

OZN

Device name

C. Difficile Toxin Gene Amplification Assay

Device class

Class 2

21 CFR

21 CFR 866.3130

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.

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

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

Last three years. Most recent: 2026-08-28.

3 summaries are archived here for direct download.