Data / Medical devices / Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (JSO): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO, Class 2, 21 CFR 866.1700). 10 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on April 29, 2019, and lists 21 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- JSO
- Device class
- 2
- Regulation
- 866.1700
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| France | 3 |
| Spain | 1 |
| United Kingdom | 1 |
Makers of Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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 | 8 | May 1, 2017 | 0 | 5 | 0 | api.fda.gov |
| Hardy Diagnostics | Orcutt, CA, United States | Manufacturer | 5 | April 29, 2019 | 0 | 7 | 0 | api.fda.gov |
| Biomerieux France | CRAPONNE Rhone, France | Manufacturer | 4 | July 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Hardy Diagnostics | Springboro, OH, United States | Manufacturer | 3 | April 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad | STEENVOORDE Nord, France | Manufacturer | 2 | December 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux SA | Combourg Ille-et-Vilaine, France | Manufacturer | 2 | July 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux Spain | Tres Cantos Madrid(Province), Spain | Manufacturer | 2 | October 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Oxoid, Ltd. | Basingstoke, Hampshire, United Kingdom | Exporter to the US, Manufacturer | 2 | June 13, 1989 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 1 | August 20, 2010 | 0 | 3 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Cockeysville, MD, United States | Manufacturer | 1 | August 20, 2010 | 0 | 0 | 0 | api.fda.gov |
Updated April 29, 2019. 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.