Data / Medical devices / Igd, Antigen, Antiserum, Control
Igd, Antigen, Antiserum, Control (CZJ): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Igd, Antigen, Antiserum, Control (product code CZJ, Class 2, 21 CFR 866.5510). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on December 28, 2009, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CZJ
- Device class
- 2
- Regulation
- 866.5510
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United Kingdom | 2 |
| United States | 2 |
Makers of Igd, 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 |
|---|---|---|---|---|---|---|---|---|
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 2 | December 28, 2009 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer | 2 | December 28, 2009 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 1 | August 12, 1987 | 0 | 0 | 0 | api.fda.gov |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 28, 2009. 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.