Gongdong
INDIVIDUALLY PACKAGED,10mL Virus Collection and Preservation System(VTM),G1029FN80 Swab,3mL VTM medium
11manufacturers in China registered for this device type
11catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| Changsha Renji Medical Equipment Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
| Huachenyang(Shenzhen)Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Zhejiang Gongdong Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | JSM |
| Device type | Culture Media, Non-Propagating Transport |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2390 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-09-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Carton of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GD080UACW | 1,000 | In distribution | |
| GD070UB | 1,000 | In distribution | |
| GD080UBW | 1,000 | In distribution | |
| GD100UBW | 1,000 | In distribution | |
| GD040UBW | 1,000 | In distribution | |
| G1026V3 | 600 | In distribution | |
| GD100UB | 1,000 | In distribution | |
| GD080UAC | 1,000 | In distribution | |
| GD070UBW | 1,000 | In distribution | |
| GD080UB | 1,000 | In distribution | |
| GD040UB | 1,000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioSci | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 27 |
| UTM® | Copan Italia | 18 |
| Bioer Viral Transport Medium | Hangzhou Bioer Technology Co., Ltd. | 15 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 13 |
| TransPorter® | Copan Italia | 13 |
| UTM-RT | Copan Italia | 12 |
| MicroTest M4RT | Remel, Inc. | 12 |
| BBL™ CultureSwab™ | Copan Italia | 11 |
| iClean | Huachenyang(Shenzhen)Technology Co., Ltd. | 11 |
| Transystem™ | Copan Italia | 10 |
| MicroTest M6 | Remel, Inc. | 9 |
| BD Universal Viral Transport | Copan Italia | 8 |
Showing 12 of 98. All products under Culture Media, Non-Propagating Transport
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220739 | 2022-11-17 |
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.