Product code OMN— Microbiology
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
- Classification name
- C. Difficile Nucleic Acid Amplification Test Assay
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Total cleared
- 5
- First cleared
- Most recent
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.”
Market context for product code OMN
FDA has cleared devices under product code OMN between 2010 and 2012, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2012
- 2011
- 2010
Top applicants under product code OMN
Recent clearances under product code OMN
Data sourced from openFDA. This site is unofficial and independent of the FDA.