The following data is part of a premarket notification filed by Qiagen, Gmbh with the FDA for Artus Infl A/b Rg Rt-pcr Kit.
| Device ID | K113323 |
| 510k Number | K113323 |
| Device Name: | ARTUS INFL A/B RG RT-PCR KIT |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | QIAGEN, GMBH 1201 CLOPPER RD Gaithersburg, MD 20878 |
| Contact | Kim Davis |
| Correspondent | Kim Davis QIAGEN, GMBH 1201 CLOPPER RD Gaithersburg, MD 20878 |
| Product Code | OCC |
| Subsequent Product Code | JJH |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-10 |
| Decision Date | 2012-02-06 |
| Summary: | summary |