Data / Medical devices / Thyroglobulin, Antigen, Antiserum, Control
Thyroglobulin, Antigen, Antiserum, Control (DDC): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Thyroglobulin, Antigen, Antiserum, Control (product code DDC, Class 2, 21 CFR 866.5870). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on January 6, 2003, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DDC
- Device class
- 2
- Regulation
- 866.5870
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Germany | 1 |
| United Kingdom | 1 |
| Japan | 1 |
Makers of Thyroglobulin, Antigen, Antiserum, 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 |
|---|---|---|---|---|---|---|---|---|
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 3 | June 25, 1999 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 3 | February 18, 2000 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 2 | June 25, 1999 | 0 | 0 | 0 | api.fda.gov |
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 1 | March 15, 1993 | 0 | 0 | 0 | api.fda.gov |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer | 1 | July 3, 1997 | 0 | 0 | 0 | api.fda.gov |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Manufacturer | 1 | June 14, 1978 | 0 | 0 | 0 | api.fda.gov |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 6, 2003. 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.