K133936 is an FDA 510(k) clearance for the ARTUS C. DIFFICILE QS-RGQ MDX KIT. This device is classified as a C. Difficile Toxin Gene Amplification Assay (Class II - Special Controls, product code OZN).
Submitted by QIAGEN GmbH (Gaithersburg, US). The FDA issued a Cleared decision on April 4, 2014, 102 days after receiving the submission on December 23, 2013.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3130. Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients..
| 510(k) Number | K133936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2013 |
| Decision Date | April 04, 2014 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OZN — C. Difficile Toxin Gene Amplification Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3130 |
| Definition | Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients. |