Data / Medical devices / Legionella, Spp., Elisa
Legionella, Spp., Elisa (MJH): 15 FDA-registered makers in 4 countries
15 establishments in 4 countries are registered with the FDA to make Legionella, Spp., Elisa (product code MJH, Class 2, 21 CFR 866.3300). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on March 5, 2020, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MJH
- Device class
- 2
- Regulation
- 866.3300
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Germany | 3 |
| United Kingdom | 2 |
| Denmark | 1 |
Makers of Legionella, Spp., Elisa
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Manufacturer | 2 | March 15, 2007 | 0 | 1 | 0 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Westbrook, ME, United States | Manufacturer | 2 | March 15, 2007 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 2 | November 26, 2003 | 0 | 2 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | November 26, 2003 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 1 | February 24, 2012 | 0 | 0 | 0 | api.fda.gov |
| SA Scientific, Ltd | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | June 28, 2007 | 0 | 0 | 0 | api.fda.gov |
| SSI Diagnostica A/S | Hilleroed Hovedstaden, Denmark | Manufacturer | 1 | March 5, 2020 | 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 | |
| Keva Inc. | Blaine, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumiquick Diagnostics, Inc. | Santa Clara, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oxoid, Ltd. | Basingstoke, Hampshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel, Inc. | Lenexa, KS, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 5, 2020. 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.