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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0329-2017

Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.

Publicado el 9 de noviembre de 2016 · Inicio del retiro: 24 de agosto de 2016

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Out of Specification Microbiological test results

Qué hacer

Voluntary: Firm initiated

Detalles del retiro

Fabricante
Azer Scientific, Inc.
Distribuidor
Nationwide Distribution
Lote
Item Number: 10-O-050 Lot Number: 51426 Expiration Date: 05/2018
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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