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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2026 | K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Cont Roche Molecular Systems, Inc. | OZN |
| Feb 28, 2025 | K243730 | Xpert C. difficile/Epi Cepheid® | OZN |
| Nov 14, 2023 | K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2) Vela Operations USA | OZN |
| Oct 20, 2021 | K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. | OZN |
| Sep 9, 2021 | K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. | OZN |
| Nov 22, 2017 | K172569 | GenePOC CDiff Genepoc, Inc., CA | OZN |
| Sep 12, 2017 | K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. | OZN |
| Jul 21, 2017 | K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cass Luminex Corporation | OZN |
| May 11, 2017 | K170491 | Solana C. difficile Assay Quidel Corporation | OZN |
| Feb 14, 2017 | K163085 | Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC | OZN |
| May 20, 2015 | K142422 | cobas Cdiff Test Roche Molecular Systems, Inc. | OZN |
| Apr 4, 2014 | K133936 | ARTUS C. DIFFICILE QS-RGQ MDX KIT QIAGEN GmbH | OZN |
| Nov 29, 2013 | K132726 | ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM Primeradx | OZN |
| Oct 11, 2013 | K132235 | IMDX C.DIFFICILE FOR ABBOTT M2000 Intelligent Medical Devices, Inc. | OZN |
| Apr 2, 2013 | K130470 | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT Geneohm Sciences Canada, Inc. (Bd Diagnostics), CA | OZN |
| Mar 8, 2013 | K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY Quidel Corp. | OZN |
| Dec 13, 2012 | K123355 | AMPLIVUE C. DIFFICILE ASSAY Quidel Corporation | OZN |
| Dec 5, 2012 | K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) Nanosphere, Inc. | OZN |
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