Adenovirus Antigen Detection Kit (Immunochromatography)
2 catalogue numbers from 1 test/kit, listed by Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China, under Antigens, Ha (Including Ha Control), Adenovirus 1-33. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Hunan (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
Record
| Listed by | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China |
|---|---|
| FDA product code | GOB |
| Device type | Antigens, Ha (Including Ha Control), Adenovirus 1-33 |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3020 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 test/kit | In distribution | |
| 20 tests/kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold) | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 2 |
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.