Data / Medical devices / Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (LJZ): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (product code LJZ, Class 1, 21 CFR 866.3375). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on January 11, 1999, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LJZ
- Device class
- 1
- Regulation
- 866.3375
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Germany | 4 |
| Israel | 1 |
| United Kingdom | 1 |
Makers of Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Savyon Diagnostics Ltd. | ASHDOD Southern, Israel | Manufacturer | 1 | June 21, 1989 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gold Standard Diagnostics Frankfurt GmbH | Dietzenbach Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 11, 1999. 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.