The following data is part of a premarket notification filed by Qiagen Gmbh with the FDA for Qiastat-dx Respiratory Panel.
| Device ID | K183597 |
| 510k Number | K183597 |
| Device Name: | QIAstat-Dx Respiratory Panel |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | QIAGEN GmbH Qiagen Strasse 1 Hilden, DE 40724 |
| Contact | Lindsey Howard |
| Correspondent | Melissa Mahall QIAGEN 19300 Germantown Road Germantown, MD 20874 |
| Product Code | OCC |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OOI |
| Subsequent Product Code | OOU |
| Subsequent Product Code | OQW |
| Subsequent Product Code | OTG |
| Subsequent Product Code | OZX |
| Subsequent Product Code | OZY |
| Subsequent Product Code | OZZ |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053228033905 | K183597 | 000 |