OMN

C. Difficile Nucleic Acid Amplification Test Assay

Product code

OMN

Device name

C. Difficile Nucleic Acid Amplification Test Assay

Device class

Class 1

21 CFR

21 CFR 866.2660

Medical specialty

Microbiology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

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