Data / Medical devices / Antigen, B. Pertussis
Antigen, B. Pertussis (GOX): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Antigen, B. Pertussis (product code GOX, Class 1, 21 CFR 866.3065). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 24, 1979, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GOX
- Device class
- 1
- Regulation
- 866.3065
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| Germany | 4 |
| United States | 3 |
| China | 1 |
Makers of Antigen, B. Pertussis
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lee Laboratories, Inc. | Grayson, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Tianlong Biotechnology Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viramed Biotech AG | PLANEGG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 24, 1979. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.