OMN — C. Difficile Nucleic Acid Amplification Test Assay Class I
Classification Details
- Product Code
- OMN
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN120013 | great basin scientific | PORTRAIT ANALYZER | April 30, 2012 |
| K113433 | focus diagnostics | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT | April 4, 2012 |
| K110203 | cepheid | XPERT C. DIFFICLE/EPI ASSAY | April 7, 2011 |
| K110012 | meridian bioscience | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 | February 24, 2011 |
| K100818 | meridian bioscience | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTR | July 9, 2010 |