Bordetella Pertussis Toxin (PT) IgG Elisa
The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate,…
The Bordetella pertussis Toxin, PT, IgG ELISA is intended for the quantitative determination of IgG class antibodies against B. pertussis toxin, PT, in human serum or plasma, -citrate, heparin.
1manufacturer
1catalogue number
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 International, Inc., 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 |
| Premarket notification | Exempt |
| Record published | 2023-08-26 |
| Record revised | 2024-09-19 (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 | 2024-09-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIA-6133 | Withdrawn |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 |
| 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.