Devices

Device Recall Glucose Tolerance Drink

  • Model / Serial
    Item Number: 10-O-050 Lot Number: 51426 Expiration Date: 05/2018
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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.
  • Manufacturer
    Azer Scientific, Inc.
  • 1 Event

Manufacturer

Azer Scientific, Inc.
  • Manufacturer Address
    Azer Scientific, Inc., 701 Hemlock Rd, Morgantown PA 19543-9768
  • Manufacturer Parent Company (2017)
    Azer Scientific Incorporated
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Glucose Tolerance Drink
  • Model / Serial
    Item Number: 10-FP-100 Lot Number: 49936 Expiration Date: 11/2017
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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.
  • Manufacturer
    Azer Scientific, Inc.