Data / Medical devices / Monitor, Microbial Growth
Monitor, Microbial Growth (JTA): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Monitor, Microbial Growth (product code JTA, Class 1, 21 CFR 866.2560). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on November 21, 1996, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JTA
- Device class
- 1
- Regulation
- 866.2560
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Italy | 1 |
| Germany | 1 |
Makers of Monitor, Microbial Growth
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 |
|---|---|---|---|---|---|---|---|---|
| Alifax SRL | Nimis Udine, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Broken Bow, NE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux, Inc. | Hazelwood, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Orcutt, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 21, 1996. 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.