Data / Medical devices / Culture Media, Single Biochemical Test
Culture Media, Single Biochemical Test (JSF): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Culture Media, Single Biochemical Test (product code JSF, Class 1, 21 CFR 866.2320). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 87 510(k) clearances under this code, the latest on April 1, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JSF
- Device class
- 1
- Regulation
- 866.2320
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| China | 2 |
| India | 2 |
| United Kingdom | 1 |
| Canada | 1 |
Makers of Culture Media, Single Biochemical Test
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 |
|---|---|---|---|---|---|---|---|---|
| Hardy Diagnostics | Orcutt, CA, United States | Manufacturer | 3 | March 31, 1988 | 0 | 0 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Manufacturer, Specification developer | 2 | April 22, 1985 | 0 | 0 | 0 | api.fda.gov |
| Analytichem Usa, Inc. | Winslow, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Cockeysville, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioteke Corporation (wuxi) Co., Ltd | Wuxi City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HBH Biotechnology Limited | Yantai Shandong, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 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 | |
| Hardy Diagnostics | Springboro, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Legacy Biologicals | Baltimore, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| pro-lab incorporated | Richmond Hill Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 1, 1988. 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.