13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intende ...



13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
Components:
Recall Date:    Jan 8, 2021
Mfg:
Cairn Diagnostics
Mfg Country:
United States
Recall ID:    87186
Product ID:    185506
Enforcement Date:    Feb 24, 2021
Last Published:    Feb 16, 2021

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Emert Number:    Z-1128-2021
Emert Status:    Announced