Panels › Microbiology › Product code OZN · Class 2
C. Difficile Toxin Gene Amplification Assay
Regulation 866.3130
1510(k)s in 12 months (18 all time)
1recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in OZN
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Molecular Systems, Inc. | 5 | 0 |
| Luminex Corporation | 1 | 3 |
| Nanosphere, Inc. | 1 | 2 |
| Quidel Corp. | 3 | 0 |
| Becton Dickinson & Co. | 0 | 2 |
| Cepheid® | 1 | 0 |
| Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC | 1 | 0 |
| Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 1 | 0 |
| Genepoc, Inc. | 1 | 0 |
| Intelligent Medical Devices, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2026 | Meridian Bioscience Inc Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 Open, Classified |
OZN | K172569 |
| Oct 23, 2025 | Becton Dickinson & Co. BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following:
1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927. Open, Classified |
OZN | K111860 K120138 +1 |
| Dec 3, 2024 | Becton Dickinson & Co. BD MAX System, BD MAX Instrument
Version or Model: 441916
Catalog Number: 441916 Open, Classified |
OZN | K111860 K120138 +1 |
| Jun 28, 2023 | Luminex Corporation VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 Open, Classified |
OZN | K123197 |
| Jun 17, 2022 | Luminex Corporation Verigene CDF Nucleic Acid Test, Part No. 30-002-22 Open, Classified |
OZN | None listed |
| Aug 15, 2019 | Luminex Corporation ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 Open, Classified |
OZN | K171441 |
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of Terminated |
OZN | K123197 |
| Aug 8, 2014 | Nanosphere, Inc. Nanosphere Verigene
Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit.
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qua Terminated |
OZN | K123197 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.