Data / Medical devices / Antigens, Ha (Including Ha Control), Adenovirus 1-33
Antigens, Ha (Including Ha Control), Adenovirus 1-33 (GOB): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Antigens, Ha (Including Ha Control), Adenovirus 1-33 (product code GOB, Class 1, 21 CFR 866.3020). 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 14, 1987, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GOB
- Device class
- 1
- Regulation
- 866.3020
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| China | 2 |
| United States | 1 |
Makers of Antigens, Ha (Including Ha Control), Adenovirus 1-33
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 |
|---|---|---|---|---|---|---|---|---|
| Ave Science & Technology Co., Ltd | Changsha Hunan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | Nantong Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keva Inc. | Blaine, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 14, 1987. 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.