Product code OZN
- Device name
- C. Difficile Toxin Gene Amplification Assay
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3130
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243730 | Xpert C. difficile/Epi | Cepheid® | 2025-02-28 |
| K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2) | Vela Operations USA | 2023-11-14 |
| K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021-10-20 |
| K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021-09-09 |
| K172569 | GenePOC CDiff | Genepoc, Inc. | 2017-11-22 |
| K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2017-09-12 |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit | Luminex Corporation | 2017-07-21 |
| K170491 | Solana C. difficile Assay | Quidel Corporation | 2017-05-11 |
| K163085 | Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC | 2017-02-14 |
| K142422 | cobas Cdiff Test | Roche Molecular Systems, Inc. | 2015-05-20 |
| K133936 | ARTUS C. DIFFICILE QS-RGQ MDX KIT | QIAGEN GmbH | 2014-04-04 |
| K132726 | ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM | Primeradx | 2013-11-29 |
| K132235 | IMDX C.DIFFICILE FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-10-11 |
| K130470 | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-04-02 |
| K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Quidel Corp. | 2013-03-08 |
| K123355 | AMPLIVUE C. DIFFICILE ASSAY | Quidel Corporation | 2012-12-13 |
| K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) | Nanosphere, Inc. | 2012-12-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G491CDF20 | Toxigenic C. difficile Direct Test | Vela Operations USA Inc. | 2024-01-18 |
| G491CDF21 | Toxigenic C. difficile Direct Test | Vela Operations USA Inc. | 2024-01-18 |
| G491CDF2SPD0 | Toxigenic C. difficile Direct Test - Sample Prep | Vela Operations USA Inc. | 2024-01-18 |
| 00840733102349 | Revogene C. difficile | MERIDIAN BIOSCIENCE, INC. | 2020-07-15 |
| 00840487101605 | Clostridium difficile (CDF) Nucleic Acid Test Cartridge | LUMINEX CORPORATION | 2019-12-05 |
| 00840487101650 | Clostridium difficile (CDF) Extraction Tray | LUMINEX CORPORATION | 2019-12-05 |
| 00840487101704 | Clostridium difficile (CDF) Amplification Tray | LUMINEX CORPORATION | 2019-12-05 |
| 00840487101735 | Clostridium difficile (CDF) Stool Sample Preparation Kit | LUMINEX CORPORATION | 2019-12-05 |
| 00628055344124 | Revogene® C. difficile | Meridian Bioscience Canada Inc | 2019-10-21 |
| 30014613336150 | Solana | DIAGNOSTIC HYBRIDS, INC. | 2018-07-20 |
| 00628055344025 | GenePOC™ CDiff | GenePoc Inc | 2017-12-29 |
| 00840487100059 | ARIES® C. difficile Assay | LUMINEX CORPORATION | 2017-07-25 |
| 20816101025590 | Simplexa™ C. difficile Direct | DIASORIN MOLECULAR LLC | 2017-02-16 |
| 20816101025606 | Simplexa™ C. difficile Positive Control Pack | DIASORIN MOLECULAR LLC | 2017-02-16 |
| 20816101025613 | Simplexa™ C.difficile Sample Prep Kit | DIASORIN MOLECULAR LLC | 2017-02-16 |
| 04053228004646 | artus® C. difficile QS-RGQ MDx Kit | QIAGEN GmbH | 2017-01-04 |
| B178GBCDIFF100 | Portrait Toxigenic C. difficile Assay | GREAT BASIN SCIENTIFIC, INC. | 2016-09-23 |
| 00857573006157 | Clostridium difficile (CDF) Nucleic Acid Test Cartridge | NANOSPHERE, INC. | 2016-09-23 |
| 00857573006256 | Clostridium difficile (CDF) Extraction Tray | NANOSPHERE, INC. | 2016-09-23 |
| 00857573006317 | Clostridium difficile (CDF) Amplification Tray | NANOSPHERE, INC. | 2016-09-23 |
| 00857573006362 | Clostridium difficile (CDF) Stool Sample Preparation Kit | NANOSPHERE, INC. | 2016-09-23 |
| 30014613311058 | Lyra | QUIDEL CORPORATION | 2016-09-15 |
| 30014613312017 | AmpliVue | QUIDEL CORPORATION | 2016-09-15 |
| 00382904434182 | BD MAX™ Cdiff (US) | BECTON, DICKINSON AND COMPANY | 2016-05-19 |
| 00382904419165 | BD MAX™ System | BECTON, DICKINSON AND COMPANY | 2016-05-19 |