The following data is part of a premarket notification filed by Qiagen, Gmbh with the FDA for Artus C. Difficile Qs-rgq Mdx Kit.
| Device ID | K133936 |
| 510k Number | K133936 |
| Device Name: | ARTUS C. DIFFICILE QS-RGQ MDX KIT |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| Applicant | QIAGEN, GMBH 1201 CLOPPER RD Gaithersburg, MD 20878 |
| Contact | Kimberly Mapp |
| Correspondent | Kimberly Mapp QIAGEN, GMBH 1201 CLOPPER RD Gaithersburg, MD 20878 |
| Product Code | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-04-04 |
| Summary: | summary |