Product code JSM
- Device name
- Culture Media, Non-Propagating Transport
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2390
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Medical Wire & Equipment Company (Bath), Ltd. | 2025-11-26 |
| K250205 | Babio® Virus Transport Kit (Non-inactivating) | Jinan Babio Biotechnology Co., Ltd. | 2025-09-22 |
| K242576 | AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 |
| K232565 | UriSponge™ | Copan Italia Spa | 2024-10-11 |
| K220908 | Ensol EnTM Specimen Collection and Transport System | Ensol Biosciences, Inc. | 2024-08-29 |
| K240235 | OmniTrans Transport System | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2024-08-19 |
| K233534 | Viral Transport Medium | Hardy Diagnostics | 2024-08-02 |
| K233449 | Avantik VTM | Hanchang Medic Co., Ltd. (Han Chang Medic) | 2024-07-15 |
| K232454 | Viral Transport Media (VTM) | Alb Luz | 2024-05-03 |
| K232357 | Copan Universal Transport Medium (UTM-RT) System | Copan Italia Spa | 2024-04-25 |
| K202531 | Azer Scientific Universal Transport Medium | Azer Scientific, Inc. | 2024-04-11 |
| K231843 | ARX Viral Transport Media Collection and Transport System | Arx Sciences, Inc. | 2024-03-19 |
| K231027 | KaiBiLi Extended ViralTrans | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | 2023-12-21 |
| K212743 | MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System | Medschenker, Inc. | 2023-05-03 |
| K230035 | BioSci™ Disposable Virus Sampling Tubes | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023-04-05 |
| K220052 | Copan FecalSwab Collection, Transport and Preservation System | Copan Italia Spa | 2022-12-16 |
| K220739 | Disposable Urine Collection Tube | Zhejiang Gongdong Medical Technology Co., Ltd. | 2022-11-17 |
| K212856 | iClean Viral Transport System (VTM-RT kit) | Huachenyang (Shenzhen) Technology Co. , Ltd. | 2022-08-18 |
| K211256 | Disposable Sampler Viral Transport Media | Wuxi Nest Biotechnology Co., Ltd. | 2022-05-20 |
| K211707 | BioTeke Sterile Disposable Virus Sampling Kit | Bioteke Corporation (Wuxi) Co., Ltd. | 2022-05-04 |
| K201674 | Cultura Collection and Transport System | Merit Medical Systems, Inc. | 2021-03-03 |
| K180052 | UriSwab-Urine Collection, Transport and Preservation System | Copan Italia Spa | 2018-03-23 |
| K163436 | Greiner Vacuette Urine Count and Culture, Mannitol tube | Greiner Bio-One Na, Inc. | 2017-03-06 |
| K162284 | Puritan Fecal Opti-Swab Collection and Transport System | Puritan Medical Products, LLC | 2016-11-04 |
| K160082 | Puritan Opti-Tranz Cary-Blair Collection and Transport System | Puritan Medical Products, LLC | 2016-07-29 |
| K150887 | Para-Fix C&S Medium | Medical Chemical Corporation | 2015-05-29 |
| K142094 | COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM | Copan Italia Spa | 2015-04-10 |
| K141506 | MCC Para-Fix CARY BLAIR MEDIUM | Medical Chemical Corporation | 2015-02-25 |
| K142366 | Puritan OptiTranz Liquid Stuart Collection and Transport System | Puritan Medical Products, LLC | 2015-01-09 |
| K113249 | TRANSPORT CULTURE MEDIUM DEVICE | Puritan Medical Products, LLC | 2012-03-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16947462494330 | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | 2023-09-13 |
| 16947462494323 | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | 2023-09-13 |
| 16947462494316 | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | 2023-09-13 |
| 16947462494309 | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | 2023-09-13 |
| 16947462494293 | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | 2023-09-13 |
| 16947462494286 | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | 2023-09-13 |
| 16947462494279 | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | 2023-09-13 |
| 16947462492817 | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | 2023-09-13 |
| 16947462494262 | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | 2023-09-07 |
| 10884450525767 | Cultura™ | Merit Medical Systems, Inc. | 2021-09-08 |
| M445892021 | Total-Fix / Formalin / C&S / Clean O&P Collection Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445892031 | Z-PVA / Formalin / C&S / Clean O&P Collection Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M4452805051 | C&S Medium | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445891201 | Formalin / C&S / Clean Stool Collection Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M44589117ORNGE1 | Total-Fix / C&S / Clean O&P Collection Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445891171 | Total-Fix / C&S / Clean O&P Collection Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445891101 | Unifix / Clean / C&S Kits O&P Collection Vials | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445891081 | O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection Kit | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445891051 | O&P Collection Vials SAF / Clean/ C&S Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445891031 | O&P Collection Vials Zinc PVA / Formalin / C&S Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445890241 | O&P Collection Vials Total Fix/C&S Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445890211 | O&P Collection Vials Formalin/C&S Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445890151 | O&P Collection Vials C&S/Clean Kits | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445280505WB1 | C&S Medium | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445280505REDSP1 | C&S Medium | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M445280505ORNG1 | C&S Medium | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| M44528050510PCK1 | C&S Medium | MEDICAL CHEMICAL CORPORATION | 2020-08-31 |
| 10885380163500 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-12-18 |
| 10885380163517 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-12-18 |
| 10885380163524 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-12-18 |