Data / Medical devices / System, Test, Systemic Lupus Erythematosus
System, Test, Systemic Lupus Erythematosus (DHC): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make System, Test, Systemic Lupus Erythematosus (product code DHC, Class 2, 21 CFR 866.5820). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on April 9, 2001, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DHC
- Device class
- 2
- Regulation
- 866.5820
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
Makers of System, Test, Systemic Lupus Erythematosus
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 |
|---|---|---|---|---|---|---|---|---|
| Arlington Scientific, Inc. | Springville, UT, United States | Contract manufacturer, Manufacturer | 1 | May 28, 1982 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Manufacturer for export | 1 | May 28, 1982 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 1 | March 15, 1979 | 0 | 0 | 0 | api.fda.gov |
| Corgenix, Inc. | Broomfield, CO, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 9, 2001. 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.