| K-number | K133936 |
| Device name | ARTUS C. DIFFICILE QS-RGQ MDX KIT |
| Applicant | QIAGEN GmbH |
| Product code | OZN |
| Device class | Class II |
| Decision date | Apr 4, 2014 |
| Decision | Substantially Equivalent |
| Regulation | 866.3130 |
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