Data / Medical devices / Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening / United States
FDA-registered makers of Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening (product code JBF). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- Product code
- JBF
- Country
- United States
Makers of Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Manufacturer | 1 | October 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Westbrook, ME, United States | Manufacturer | 1 | October 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Baebies Inc. | Durham, NC, United States | Manufacturer | 1 | September 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Manufacturer | 1 | March 31, 2003 | 0 | 1 | 0 | api.fda.gov |
| Access Bio, Inc. | Monroe Township, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.