Data / Medical devices / Culture Media, Selective And Differential
Culture Media, Selective And Differential (JSI): 29 FDA-registered makers in 11 countries
29 establishments in 11 countries are registered with the FDA to make Culture Media, Selective And Differential (product code JSI, Class 1, 21 CFR 866.2360). 5 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 285 510(k) clearances under this code, the latest on November 20, 2007, and lists 16 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JSI
- Device class
- 1
- Regulation
- 866.2360
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| France | 4 |
| India | 3 |
| United Kingdom | 2 |
| Israel | 1 |
| Finland | 1 |
| Spain | 1 |
| Taiwan | 1 |
| China | 1 |
| Denmark | 1 |
| South Korea | 1 |
Makers of Culture Media, Selective And Differential
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 |
|---|---|---|---|---|---|---|---|---|
| Remel, Inc. | Lenexa, KS, United States | Manufacturer | 7 | June 24, 1987 | 0 | 4 | 0 | api.fda.gov |
| Oxoid, Ltd. | Basingstoke, Hampshire, United Kingdom | Exporter to the US, Manufacturer | 2 | August 10, 1987 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 1 | November 20, 2007 | 0 | 5 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Cockeysville, MD, United States | Manufacturer | 1 | November 20, 2007 | 0 | 0 | 0 | api.fda.gov |
| Savyon Diagnostics Ltd. | ASHDOD Southern, Israel | Manufacturer | 1 | July 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Aidian OY | ESPOO Uusimaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anaerobe Systems | Morgan Hill, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Analytichem Usa, Inc. | Winslow, ME, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Bio-Rad | STEENVOORDE Nord, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux France | CRAPONNE Rhone, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux SA | Combourg Ille-et-Vilaine, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux Spain | Tres Cantos Madrid(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chromagar | Saint-Denis Seine-Saint-Denis, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Life Science Co., Ltd. | Xinzhuang District New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Consulting Network, LLC. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Huankai Biology Sci.&tech.co.,ltd | Zhaoqing Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Orcutt, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Himedia Laboratories Private Limited | DOMBIVLI, THANE Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Himedia Laboratories Private Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Himedia Laboratories Private Limited | Thane Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Springboro, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K&R Technologies Dba Microbiology International | Frederick, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Key Scientific Products | Stamford, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Legacy Biologicals | Baltimore, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifesign L.L.C. | Skillman, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Wire And Equipment Co. Ltd. | Corsham, Wiltshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S2media | Spokane Valley, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SSI Diagnostica A/S | Hilleroed Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yong Chang Co., Ltd. | Gimpo Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 20, 2007. 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.