Data / Medical devices / Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening (JBF): 6 FDA-registered makers in 2 countries
6 establishments in 2 countries are registered with the FDA to make Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening (product code JBF, Class 2, 21 CFR 864.7360). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on September 14, 2022, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JBF
- Device class
- 2
- Regulation
- 864.7360
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Ireland | 1 |
Makers of Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Trinity Biotech, Plc | BRAY Wicklow, Ireland | Manufacturer | 1 | June 29, 1995 | 0 | 0 | 0 | api.fda.gov |
| Access Bio, Inc. | Monroe Township, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 14, 2022. 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.