| Xpert C. difficile/Epi (K243730) | Cepheid® | 2025-02-28 |
| Great Basin Toxigenic C. difficile Direct Test (CDF2) (K232092) | Vela Operations USA | 2023-11-14 |
| cobas Cdiff nucleic acid test for use on the cobas Liat System (K212427) | Roche Molecular Systems, Inc. | 2021-10-20 |
| cobas Cdiff nucleic acid test for use on the cobas Liat System (K210385) | Roche Molecular Systems, Inc. | 2021-09-09 |
| GenePOC CDiff (K172569) | Genepoc, Inc. | 2017-11-22 |
| cobas Cdiff Nucleic acid test for use on the cobas Liat System (K171770) | Roche Molecular Systems, Inc. | 2017-09-12 |
| ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit (K171441) | Luminex Corporation | 2017-07-21 |
| Solana C. difficile Assay (K170491) | Quidel Corporation | 2017-05-11 |
| Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (K163085) | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC | 2017-02-14 |
| cobas Cdiff Test (K142422) | Roche Molecular Systems, Inc. | 2015-05-20 |
| ARTUS C. DIFFICILE QS-RGQ MDX KIT (K133936) | QIAGEN GmbH | 2014-04-04 |
| ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM (K132726) | Primeradx | 2013-11-29 |
| IMDX C.DIFFICILE FOR ABBOTT M2000 (K132235) | Intelligent Medical Devices, Inc. | 2013-10-11 |
| BD MAX CDIFF ASSAY, BD MAX INSTRUMENT (K130470) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-04-02 |
| QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY (K123998) | Quidel Corp. | 2013-03-08 |
| AMPLIVUE C. DIFFICILE ASSAY (K123355) | Quidel Corporation | 2012-12-13 |
| VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) (K123197) | Nanosphere, Inc. | 2012-12-05 |