Data / Medical devices / Assay, Erythropoietin
Assay, Erythropoietin (GGT): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Assay, Erythropoietin (product code GGT, Class 2, 21 CFR 864.7250). 6 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on April 22, 2024, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GGT
- Device class
- 2
- Regulation
- 864.7250
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 2 |
| Germany | 1 |
Makers of Assay, Erythropoietin
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 |
|---|---|---|---|---|---|---|---|---|
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 2 | April 22, 2024 | 0 | 1 | 0 | api.fda.gov |
| R & D Systems, Inc. | Minneapolis, MN, United States | Manufacturer | 2 | July 19, 1994 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | August 2, 2019 | 0 | 1 | 0 | api.fda.gov |
| Biomerica | Irvine, CA, United States | Manufacturer | 1 | June 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 1 | June 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | July 12, 1999 | 0 | 0 | 0 | api.fda.gov |
| Axis-Shield Diagnostics, Ltd. | DUNDEE Scotland, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 22, 2024. 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.