BEUDAMED
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    AZER SCIENTIFIC, INC.

    FDA registration
    AZER SCIENTIFIC, INC.·63 products·🇺🇸 United States

    PRE-FILLED FORMALIN

    FDA Adverse Event
    Malfunction ·AZER SCIENTIFIC, INC.·Product code IFP·September 13, 2024

    480 ML HALF-FILLED 10% NEUTRAL BUFFERED FORMALIN

    FDA Adverse Event
    Malfunction ·AZER SCIENTIFIC, INC.·Product code IFP·August 7, 2025

    VACUTAINER

    FDA Adverse Event
    Malfunction ·AZER SCIENTIFIC, INC.·Product code JKA·September 22, 2022

    GLUCOSE TOLERANCE BEVERAGE

    FDA Adverse Event
    Malfunction ·AZER SCIENTIFIC, INC.·Product code MRV·November 20, 2024

    BUFFERED SALINE SOLUTION 0.85%

    FDA Adverse Event
    Malfunction ·AZER SCIENTIFIC INC.·Product code JSG·January 7, 2022

    BUFFERED SALINE SOLUTION 0.85% SPECIMEN CONTAINER

    FDA Adverse Event
    Malfunction ·AZER SCIENTIFIC, INC·Product code JSG·January 5, 2022

    BUFFERED SALINE SOLUTION 0.85%

    FDA Adverse Event
    Malfunction ·AZER SCIENTIFIC INC.·Product code JSG·January 7, 2022

    Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs 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.

    FDA Recall
    Terminated ·Azer Scientific, Inc.·Product code MRV·August 24, 2016

    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.

    FDA Recall
    Terminated ·Azer Scientific, Inc.·Product code MRV·August 24, 2016

    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.

    FDA Enforcement
    Class II ·Terminated·Azer Scientific, Inc.·November 9, 2016

    Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs 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.

    FDA Enforcement
    Class II ·Terminated·Azer Scientific, Inc.·November 9, 2016

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    Kingsmead Service B.V.

    Authorized representative
    🇳🇱 Netherlands·243 Manufacturers·2698 Devices

    RIOMAVIX LTD

    Authorized representative
    🇪🇸 Spain·400 Manufacturers·4531 Devices

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices