KaiBiLi Extended ViralTrans
3 mL viral transport medium/vial, with a regular swab and a minitip swab.
11manufacturers in China registered for this device type
8catalogue 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 | Hangzhou Genesis Biodetection & Biocontrol 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 |
| Record published | 2024-02-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 8 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M221011 | 50 | In distribution | |
| M221001 | 50 | In distribution | |
| M221007 | 50 | In distribution | |
| M221006 | 50 | In distribution | |
| M221009 | 50 | In distribution | |
| M221010 | 50 | In distribution | |
| M221008 | 50 | In distribution | |
| M221012 | 50 | 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 |
| Gongdong | Zhejiang Gongdong Medical Technology Co., Ltd. | 11 |
| Transystem™ | Copan Italia | 10 |
| MicroTest M6 | Remel, Inc. | 9 |
Showing 12 of 98. All products under Culture Media, Non-Propagating Transport
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231027 | 2023-12-21 |
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.