Data / Medical devices / Culture Media, Antibiotic Assay
Culture Media, Antibiotic Assay (JSA): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Culture Media, Antibiotic Assay (product code JSA, Class 1, 21 CFR 866.2350). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on April 18, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JSA
- Device class
- 1
- Regulation
- 866.2350
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| India | 3 |
| China | 2 |
| United States | 1 |
| United Kingdom | 1 |
Makers of Culture Media, Antibiotic Assay
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 |
|---|---|---|---|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co.,ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 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 | |
| Himedia Laboratories Private Limited | Thane Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Legacy Biologicals | Baltimore, MD, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oxoid, Ltd. | Basingstoke, Hampshire, United Kingdom | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saferlife Products Co.,ltd. | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 18, 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.