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Pointe G6PD Reagent

HORIBA INSTRUMENTS INCORPORATED · Model G7583-180 · UDI-DI 00811727014139

JBF Prescription
1
510(k) clearances
7
Adverse events
1
Recalls
6
Facilities

Description

Pointe G6PD Reagent, 10 x 6ml, 1 x 120ml kit, For the quantitative, kinetic determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.

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 in an out of specif

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.