Data / Medical devices / Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. / United States
FDA-registered makers of Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (product code LJZ). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- Product code
- LJZ
- Country
- United States
Makers of Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 2 | August 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Genbio | San Diego, CA, United States | Manufacturer | 2 | May 5, 1997 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 2 | August 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 1 | September 20, 1994 | 0 | 1 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Specification developer | 1 | June 29, 1992 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.