QuickVue
QkVue RSV 20T
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yiwu Daqida Plastic Products Co., Ltd. | Yiwu | Zhejiang | Repacker / relabeller | 9 |
Record
| Listed by | Quidel Corp., United States |
|---|---|
| FDA product code | MCE |
| Device type | Respiratory Syncytial Virus – Elisa |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3480 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-11-10 |
| Record revised | 2025-11-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | expiry date |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20193 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RSV IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Anti-RSV Elisa (IgM) | Euroimmun Medizinische Labordiagnostika AG | 1 |
| RSV IgG Elisa | DRG International, Inc. | 1 |
| NovaLisa Respiratory Syncytial Virus IgG | Gold Standard Diagnostics Frankfurt GmbH | 1 |
| Anti-RSV Elisa (IgG) | Euroimmun Medizinische Labordiagnostika AG | 1 |
| Anti-RSV Elisa (IgA) | Euroimmun Medizinische Labordiagnostika AG | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061008 | 2006-09-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.