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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2025 | Meridian Bioscience Inc Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay Open, Classified |
OMN | K110012 |
| Jun 27, 2014 | Meridian Bioscience Inc illumipro-10 Incubator/Reader, Meridian Bioscience, Inc.
The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and re Terminated |
OMN | K110012 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.