RSV IgG Elisa
The DRG RSV IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Respiratory Syncytial Virus (RSV) in serum. This…
The DRG RSV IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Respiratory Syncytial Virus (RSV) in serum. This assay is intended for in vitro diagnostic use only.
1manufacturer
2catalogue numbers in this listing
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 | DRG Instruments Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | MCE |
| Device type | Respiratory Syncytial Virus – Elisa |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3480 |
| Premarket notification | Exempt |
| Record published | 2021-06-07 |
| Record revised | 2024-11-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2024-11-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIA-3507 | In distribution | |
| EIA-3507 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.