Data / Medical devices / Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. (DOY): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. (product code DOY, Class 2, 21 CFR 862.3320). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on April 9, 1991, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- DOY
- Device class
- 2
- Regulation
- 862.3320
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Costa Rica | 1 |
Makers of Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
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 |
|---|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 1 | May 25, 1983 | 0 | 0 | 0 | api.fda.gov |
| Bayer Medical Care Inc. | Indianola, PA, United States | Manufacturer | 1 | May 9, 1983 | 0 | 0 | 0 | api.fda.gov |
| Bayer Medical SRL | Barreal de Heredia, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 9, 1991. 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.