Babio
6 catalogue numbers from 50 Tests, 3 mL Babio® VTM tubes, One Nas, listed by Jinan Babio Biotechnology Co., Ltd., China, under Culture Media, Non-Propagating Transport. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
6catalogue 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 | Jinan Babio Biotechnology Co., Ltd., China |
|---|---|
| FDA product code | JSM |
| Device type | Culture Media, Non-Propagating Transport |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2390 |
| Establishment | Manufacturer, Exporter |
| Record published | 2026-01-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50 Tests, 3 mL Babio® VTM tubes, One Nasal Swab(N15080) | In distribution | |
| 50 Tests,3 mL Babio® VTM tubes,One Nasal Swab (N15080) & One Throat Swab(T15030) | In distribution | |
| 600 Tests, 3 mL Babio® VTM tubes, One Nasal Swab(N10030) | In distribution | |
| 50 Tests, 3 mL Babio® VTM tubes, One Nasal Swab(N15080) &One Throat Swab(T15080) | In distribution | |
| 50 Tests, 3 mL Babio® VTM tubes, One Throat Swab(T15080) | In distribution | |
| 50 Tests, 3 mL Babio® VTM tubes, One Throat Swab(T15030) | 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 |
|---|---|
| K250205 | 2025-09-22 |
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.