The following data is part of a premarket notification filed by Qiagen with the FDA for Artus Hsv-1/2 Qs-rgq Mdx Kit.
| Device ID | K142738 |
| 510k Number | K142738 |
| Device Name: | Artus HSV-1/2 QS-RGQ MDx Kit |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | QIAGEN 19300 GERMANTOWN ROAD Germantown, MD 20874 |
| Contact | Lindsey Howard |
| Correspondent | Kimberly Mapp QIAGEN Gaitherburg 1201 Clopper Road Gaithersburg, MD 20878 |
| Product Code | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-23 |
| Decision Date | 2014-12-19 |
| Summary: | summary |