Data / Medical devices / Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control (LRM): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control (product code LRM, Class 2, 21 CFR 866.5100). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 29 510(k) clearances under this code, the latest on December 9, 2010, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- LRM
- Device class
- 2
- Regulation
- 866.5100
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Germany | 3 |
Makers of Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
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 |
|---|---|---|---|---|---|---|---|---|
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 2 | November 21, 2006 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 20, 1996 | 0 | 1 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 1 | November 9, 1995 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | December 23, 1992 | 0 | 0 | 0 | api.fda.gov |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 1 | April 15, 2009 | 0 | 0 | 0 | api.fda.gov |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 1 | April 15, 2009 | 0 | 0 | 0 | api.fda.gov |
| Gold Standard Diagnostics, LLC | Davis, CA, United States | Repackager or relabeler, Specification developer | 1 | February 18, 2000 | 0 | 0 | 0 | api.fda.gov |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 1 | December 9, 2010 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 1 | December 23, 1992 | 0 | 0 | 0 | api.fda.gov |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theratest Laboratories, Inc. | Lombard, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 9, 2010. 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.