Data / Medical devices / Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (LJB): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (product code LJB, Class 1, 21 CFR 866.3520). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on January 28, 1998, and lists 6 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- LJB
- Device class
- 1
- Regulation
- 866.3520
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Germany | 3 |
| Italy | 2 |
| France | 1 |
Makers of Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
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 |
|---|---|---|---|---|---|---|---|---|
| Gold Standard Diagnostics, LLC | Davis, CA, United States | Repackager or relabeler, Specification developer | 1 | January 28, 1998 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 1 | February 24, 1988 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux SA | MARCY L ETOILE Rhone, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Calbiotech, Inc. | El Cajon, CA, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Diesse Diagnostica Senese S.P.A | MONTERIGGIONI Siena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSorin Italia S.p.A. | SALUGGIA Vercelli, Italy | 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 | |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov |
Updated January 28, 1998. 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.