Data / Medical devices / Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (DBL): 6 FDA-registered makers in 1 country
6 establishments in 1 country are registered with the FDA to make Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL, Class 2, 21 CFR 866.5660). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on October 19, 2018, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DBL
- Device class
- 2
- Regulation
- 866.5660
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
Makers of Multiple Autoantibodies, Indirect Immunofluorescent, 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 |
|---|---|---|---|---|---|---|---|---|
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 5 | September 26, 1994 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 3 | April 10, 1996 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | August 12, 1981 | 0 | 0 | 0 | api.fda.gov |
| IMMUNO CONCEPTS, NA, Ltd. | Sacramento, CA, United States | Manufacturer | 1 | October 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 1 | April 23, 1996 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago, Inc. | Parsippany, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 19, 2018. 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.