Bordetella Pertussis IgG Elisa
The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and…
The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma). This assay is intended for in vitro diagnostic use only.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Tianlong Biotechnology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | DRG Instruments Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | GOX |
| Device type | Antigen, B. Pertussis |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3065 |
| Premarket notification | Exempt |
| Record published | 2021-06-07 |
| Record revised | 2024-11-21 (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 | 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-3450 | In distribution | |
| EIA-3450 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trinity Biotech | Mardx Diagnostics, Inc. | 5 |
| Euroline Bordetella pertussis (IgA) | Euroimmun Medizinische Labordiagnostika AG | 2 |
| Bordetella pertussis Toxin (PT) IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Euroline Bordetella pertussis (IgG) | Euroimmun Medizinische Labordiagnostika AG | 2 |
| Anti-Bordetella pertussis toxin Elisa (IgG) | Euroimmun Medizinische Labordiagnostika AG | 1 |
| Anti-Bordetella pertussis Elisa (IgM) | Euroimmun Medizinische Labordiagnostika AG | 1 |
| Anti-Bordetella pertussis toxin Elisa (IgA) | Euroimmun Medizinische Labordiagnostika AG | 1 |
| Bordetella pertussis ViraStripe IgG Deca Kit | Viramed Biotech AG | 1 |
| Bordetella pertussis ViraStripe IgA Deca Kit | Viramed Biotech AG | 1 |
| Bordetella pertussis ViraStripe IgA Test Kit | Viramed Biotech AG | 1 |
| Bordetella pertussis IgG Elisa | DRG International, Inc. | 1 |
| BD Difco™ Bordetella Pertussis Antigen | Becton, Dickinson AND Company | 1 |
Showing 12 of 15. All products under Antigen, B. Pertussis
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.