Data / Medical devices / Radioimmunoassay, Gastrin
Radioimmunoassay, Gastrin (CGC): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Radioimmunoassay, Gastrin (product code CGC, Class 1, 21 CFR 862.1325). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on May 30, 1996, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CGC
- Device class
- 1
- Regulation
- 862.1325
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| United Kingdom | 1 |
| Finland | 1 |
Makers of Radioimmunoassay, Gastrin
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | January 30, 1984 | 0 | 0 | 0 | api.fda.gov |
| Biohit Oyj | HELSINKI Uusimaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MP Biomedicals Diagnostics Division | Solon, OH, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 30, 1996. 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.