JSM · Culture Media, Non-Propagating Transport
Microbiology · 21 CFR 866.2390 · Class 1
Overview
| Product Code | JSM |
|---|---|
| Device Name | Culture Media, Non-Propagating Transport |
| Regulation | 21 CFR 866.2390 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (20 of 111)
Showing 20 most recent of 111 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Medical Wire & Equipment Company (Bath), Ltd. | Nov 26, 2025 | SESE |
| K250205 | Babio® Virus Transport Kit (Non-inactivating) | Jinan Babio Biotechnology Co., Ltd. | Sep 22, 2025 | SESE |
| K242576 | AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co., Ltd. | Apr 4, 2025 | SESE |
| K232565 | UriSponge | Copan Italia Spa | Oct 11, 2024 | SESE |
| K220908 | Ensol EnTM Specimen Collection and Transport System | Ensol Biosciences, Inc. | Aug 29, 2024 | SESE |
| K240235 | OmniTrans Transport System | Shenzhen Dakewe Bio-Engineering Co., Ltd. | Aug 19, 2024 | SESE |
| K233534 | Viral Transport Medium | Hardy Diagnostics | Aug 2, 2024 | SESE |
| K233449 | Avantik VTM | Hanchang Medic Co., Ltd. (Han Chang Medic) | Jul 15, 2024 | SESE |
| K232454 | Viral Transport Media (VTM) | Alb Luz | May 3, 2024 | SESE |
| K232357 | Copan Universal Transport Medium (UTM-RT) System | Copan Italia Spa | Apr 25, 2024 | SESE |
| K202531 | Azer Scientific Universal Transport Medium | Azer Scientific, Inc. | Apr 11, 2024 | SESE |
| K231843 | ARX Viral Transport Media Collection and Transport System | Arx Sciences, Inc. | Mar 19, 2024 | SESE |
| K231027 | KaiBiLi Extended ViralTrans | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | Dec 21, 2023 | SESE |
| K212743 | MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System | Medschenker, Inc. | May 3, 2023 | SESE |
| K230035 | BioSci Disposable Virus Sampling Tubes | Shenzhen Dakewe Bio-Engineering Co., Ltd. | Apr 5, 2023 | SESE |
| K220052 | Copan FecalSwab Collection, Transport and Preservation System | Copan Italia Spa | Dec 16, 2022 | SESE |
| K220739 | Disposable Urine Collection Tube | Zhejiang Gongdong Medical Technology Co., Ltd. | Nov 17, 2022 | SESE |
| K212856 | iClean Viral Transport System (VTM-RT kit) | Huachenyang (Shenzhen) Technology Co. , Ltd. | Aug 18, 2022 | SESE |
| K211256 | Disposable Sampler Viral Transport Media | Wuxi Nest Biotechnology Co., Ltd. | May 20, 2022 | SESE |
| K211707 | BioTeke Sterile Disposable Virus Sampling Kit | Bioteke Corporation (Wuxi) Co., Ltd. | May 4, 2022 | SESE |
Top Applicants
- Copan Diagnostics, Inc. — 8 clearances
- Ncs Diagnostics, Inc. — 7 clearances
- Medical Packaging Corp. — 6 clearances
- Copan Italia Spa — 5 clearances
- Precision Dynamics Corp. — 5 clearances
