FDA Product Code
FDA Product Code OZN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3130
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) | Roche Molecular Systems, Inc. | 2026-08-28 | Traditional | PDF ↗ |
| K243730 | Xpert C. difficile/Epi | Cepheid® | 2025-02-28 | Traditional | PDF ↗ |
| K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2) | Vela Operations USA | 2023-11-14 | Traditional | PDF ↗ |
| K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021-10-20 | Special | PDF ↗ |
| K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021-09-09 | Special | PDF ↗ |
| K172569 | GenePOC CDiff | Genepoc, Inc. | 2017-11-22 | Traditional | PDF ↗ |
| K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2017-09-12 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K170491 | Solana C. difficile Assay | Quidel Corporation | 2017-05-11 | Traditional | PDF ↗ |
| K163085 | Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC | 2017-02-14 | Traditional | PDF ↗ |
| K142422 | cobas Cdiff Test | Roche Molecular Systems, Inc. | 2015-05-20 | Traditional | PDF ↗ |
| K133936 | ARTUS C. DIFFICILE QS-RGQ MDX KIT | QIAGEN GmbH | 2014-04-04 | Traditional | PDF ↗ |
| K132726 | ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM | Primeradx | 2013-11-29 | Traditional | PDF ↗ |
| K132235 | IMDX C.DIFFICILE FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-10-11 | Traditional | PDF ↗ |
| K130470 | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-04-02 | Traditional | PDF ↗ |
| K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Quidel Corp. | 2013-03-08 | Traditional | PDF ↗ |
| K123355 | AMPLIVUE C. DIFFICILE ASSAY | Quidel Corporation | 2012-12-13 | Traditional | PDF ↗ |
| K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) | Nanosphere, Inc. | 2012-12-05 | Traditional | PDF ↗ |
Product code OZN · Class II · Microbiology. Data: openFDA.