Data / Medical devices / Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control / United States
FDA-registered makers of Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control (product code LRM). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- Product code
- LRM
- Country
- United States
Makers of Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control in the United States
| 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 |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | December 23, 1992 | 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 November 2, 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.