Device type
C. Difficile Toxin Gene Amplification Assay
Product code OZN · Class II · 21 CFR 866.3130 · Microbiology
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Recent 510(k)s
Aug 28, 2026
K260045
cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)
Roche Molecular Systems, Inc.
- OZN
- Class II
Recent recalls
No recalls in the archive for OZN.