Babio
Babio® Virus Transport Kit (Non-inactivated) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. It…
Babio® Virus Transport Kit (Non-inactivated) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. It measures viral particles in the samples using molecular or antigen assays. Not intended for internal use.
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (1), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Jiangsu Rongye Technology Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 16 |
| Changsha Renji Medical Equipment Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
Record
| Listed by | Jinan Babio Biotechnology Co., Ltd., China |
|---|---|
| FDA product code | QMC |
| Device type | Transport Medium, Notified Per The Vtm Guidance |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2390 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-02-02 |
| Record revised | 2023-05-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VTM | In distribution | |
| VTM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biosci™ | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 3 |
| SNT Biotech | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 2 |
| Transport Medium, Notified Per The Vtm Guidance | Hardy Diagnostics | 1 |
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.