DeviceClearance

Product code OZN— Microbiology

cobas Cdiff nucleic acid test for use on the cobas Liat System

Classification name
C. Difficile Toxin Gene Amplification Assay
Device class
Class 2
Regulation
21 CFR 866.3130
Advisory panel
Microbiology
Total cleared
18
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OZN under 21 CFR 866.3130, via openFDA

Market context for product code OZN

FDA has cleared 18 devices under product code OZN between 2012 and 2026, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OZN

Recent clearances under product code OZN

Data sourced from openFDA. This site is unofficial and independent of the FDA.