OMN
5 FDA 510(k) clearances · Product code
73 daysmedian time to decision
135 days90th percentile
5clearances measured
FDA profile
- Official device name
- C. Difficile Nucleic Acid Amplification Test Assay
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PORTRAIT ANALYZER (DEN120013) | Great Basin Scientific | 2012-04-30 |
| SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (K113433) | Focus Diagnostics, Inc. | 2012-04-04 |
| XPERT C. DIFFICLE/EPI ASSAY (K110203) | Cepheid | 2011-04-07 |
| ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (K110012) | Meridian Bioscience, Inc. | 2011-02-24 |
| ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 (K100818) | Meridian Bioscience, Inc. | 2010-07-09 |
Track OMN automatically
Every clearance here is in the API, with alerts when new ones post.