Panels › Microbiology › Product code OMN · Class 1
C. Difficile Nucleic Acid Amplification Test Assay
Regulation 866.2660
0510(k)s in 12 months (5 all time)
1recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OMN
| Company | 510(k)s | Recalls |
|---|---|---|
| Meridian Bioscience, Inc. | 2 | 2 |
| Cepheid | 1 | 0 |
| Focus Diagnostics, Inc. | 1 | 0 |
| Great Basin Scientific | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2012 | DEN120013 | PORTRAIT ANALYZER Great Basin Scientific | OMN |
| Apr 4, 2012 | K113433 | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT Focus Diagnostics, Inc. | OMN |
| Apr 7, 2011 | K110203 | XPERT C. DIFFICLE/EPI ASSAY Cepheid | OMN |
| Feb 24, 2011 | K110012 | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 Meridian Bioscience, Inc. | OMN |
| Jul 9, 2010 | K100818 | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 Meridian Bioscience, Inc. | OMN |
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