Data / Medical devices / Culture Media, Non-Propagating Transport
Culture Media, Non-Propagating Transport (JSM): 46 FDA-registered makers in 12 countries
46 establishments in 12 countries are registered with the FDA to make Culture Media, Non-Propagating Transport (product code JSM, Class 1, 21 CFR 866.2390). 30 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 111 510(k) clearances under this code, the latest on November 26, 2025, and lists 11 recall events (1 Class I). FDA data exported November 3, 2026.
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- Product code
- JSM
- Device class
- 1
- Regulation
- 866.2390
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 21 |
| China | 12 |
| Italy | 2 |
| United Kingdom | 2 |
| South Korea | 2 |
| Canada | 1 |
| Austria | 1 |
| Germany | 1 |
| Brazil | 1 |
| Sweden | 1 |
| India | 1 |
| Ireland | 1 |
Makers of Culture Media, Non-Propagating Transport
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Copan Italia | BRESCIA Lombardy, Italy | Contract manufacturer, Manufacturer | 12 | October 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 5 | September 18, 1996 | 0 | 1 | 0 | api.fda.gov |
| Copan Diagnostics, Inc. | Murrieta, CA, United States | Contract manufacturer, Repackager or relabeler | 2 | April 10, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medical Chemical Corporation | Torrance, CA, United States | Manufacturer | 2 | May 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 2 | August 28, 1985 | 0 | 0 | 0 | api.fda.gov |
| Medegen Medical Products | Gallaway, TN, United States | Specification developer | 2 | August 13, 2003 | 0 | 0 | 0 | api.fda.gov |
| Pretium Canada Packaging ULC | ETOBICOKE Ontario, Canada | Manufacturer | 2 | August 13, 2003 | 0 | 0 | 0 | api.fda.gov |
| Puritan Medical Products Company LLC | Guilford, ME, United States | Manufacturer | 2 | November 4, 2016 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 2 | August 15, 1994 | 0 | 0 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 1 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Arx Sciences | Amherst, NY, United States | Manufacturer | 1 | March 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 1 | March 26, 2003 | 0 | 1 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Broken Bow, NE, United States | Manufacturer | 1 | March 26, 2003 | 0 | 0 | 0 | api.fda.gov |
| Bioteke Corporation (wuxi) Co., Ltd | Wuxi City Jiangsu, China | Exporter to the US, Manufacturer | 1 | May 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| COPAN Diagnostics, Inc. | Carlsbad, CA, United States | Contract manufacturer, Repackager or relabeler | 1 | December 7, 2004 | 0 | 0 | 0 | api.fda.gov |
| Greiner Bio-One GMBH | KREMSMUENSTER Oberosterreich, Austria | Manufacturer, Specification developer | 1 | March 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 1 | December 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hardy Diagnostics | Orcutt, CA, United States | Manufacturer | 1 | August 2, 2024 | 0 | 1 | 0 | api.fda.gov |
| Huachenyang(shenzhen)technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | August 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hardy Diagnostics | Springboro, OH, United States | Manufacturer | 1 | August 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Jinan Babio Biotechnology Co.,ltd. | Jinan City Shandong, China | Exporter to the US, Manufacturer | 1 | September 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medical Wire And Equipment Co. Ltd. | Corsham, Wiltshire, United Kingdom | Manufacturer | 1 | June 23, 1987 | 0 | 0 | 0 | api.fda.gov |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Specification developer | 1 | April 20, 1987 | 0 | 0 | 0 | api.fda.gov |
| Sarstedt AG & Co. KG | NUMBRECHT North Rhine-Westphalia, Germany | Manufacturer | 1 | April 14, 2003 | 0 | 0 | 0 | api.fda.gov |
| Vectornate Korea Inc | Jangseong-gun Jeonnam, South Korea | Reprocessor, Specification developer | 1 | May 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Gongdong Medical Technology Co., Ltd | TAIZHOU Zhejiang, China | Manufacturer | 1 | November 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| bioBoaVista | Valinhos Sao Paulo, Brazil | Manufacturer | 1 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Azer Scientific, Inc. | Morgantown, PA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cepheid AB | SOLNA Stockholm, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Renji Medical Equipment Co., Ltd. | Changsha Hunan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Citotest Scientific Co.,ltd. | Nanjing Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cepheid | Lodi, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Industries, Inc. | Aguadilla, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Himedia Laboratories Private Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liofilchem S.R.L. | Roseto degli Abruzzi Teramo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MML Diagnostics Packaging, Inc. | Troutdale, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trinity Biotech, Plc | BRAY Wicklow, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Nest Biotechnology Co., Ltd | Wuxi Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xcell Therapeutics Inc. | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.