Bordetella Pertussis IgG Elisa
The Bordetella pertussis / toxin IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Bordetella pertussis and…
The Bordetella pertussis / toxin IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum. This assay is intended for in vitro diagnostic use.
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 | American Laboratory Products Company, United States |
|---|---|
| FDA product code | GOX |
| Device type | Antigen, B. Pertussis |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3065 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-06-18 |
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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-BPGHU-E01 | In distribution |
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 |
| Bordetella pertussis IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 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 |
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.