TransPRO
TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-tip, flocked swab with 80mm breakpoint. Hardy Diagnostics’…
TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-tip, flocked swab with 80mm breakpoint. Hardy Diagnostics’ Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory.
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 | Hardy Diagnostics, United States |
|---|---|
| FDA product code | JSM |
| Device type | Culture Media, Non-Propagating Transport |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2390 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K233534 |
| Record published | 2024-10-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TPV50 | 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 |
|---|---|
| K233534 | 2024-08-02 |
| K993812 | 1999-12-21 |
| K955451 | 1996-07-22 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-10-23 | Class II | Material/Component Contamination | There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing. | 686,920 devices | 2022-09-20 |
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.