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Gastric Emptying Breath Test

FDA product code PGE · Class 3 · Unknown

1
Registered devices
1
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

13C-Spirulina GEBT — ADVANCED BREATH DIAGNOSTICS, LLC

Recent recalls

DateFirmReason
2021-01-08Cairn DiagnosticsPotential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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