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Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

FDA product code JBF · Class 2 · Hematology

6
Registered devices
7
Adverse events
1
Recalls
5
510(k) clearances

Devices with this code

FINDER — Baebies, Inc.FINDER — Baebies, Inc.BinaxNOW® G6PD — Alere Scarborough, Inc.Pointe G6PD Controls — HORIBA INSTRUMENTS INCORPORATEDFINDER — Baebies, Inc.Pointe G6PD Reagent — HORIBA INSTRUMENTS INCORPORATED

Recent recalls

DateFirmReason
2015-05-19Pointe Scientific, Inc.A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.