NovaLisa Respiratory Syncytial Virus IgG
The Respiratory Syncytial Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against respiratory syncytial virus in human serum or plasma (citrate,…
The Respiratory Syncytial Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against respiratory syncytial virus in human serum or plasma (citrate, heparin).
1manufacturer
1catalogue number
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 | Gold Standard Diagnostics Frankfurt GmbH, Germany |
|---|---|
| FDA product code | MCE |
| Device type | Respiratory Syncytial Virus – Elisa |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3480 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-26 |
| Record revised | 2024-09-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RSVG0380 | 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 |
| Anti-RSV Elisa (IgG) | Euroimmun Medizinische Labordiagnostika AG | 1 |
| QuickVue | Quidel Corp. | 1 |
| Anti-RSV Elisa (IgA) | Euroimmun Medizinische Labordiagnostika AG | 1 |
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.