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Manufacturers
Pointe Scientific, Inc.
Manufacturer Address
Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188
Manufacturer Parent Company (2017)
MedTest Holdings
Source
USFDA
45 Events
Recall of Pointe Scientific Liquid Glucose (HEXO) Reagent Set
Recall of Glucose Hexokinase (Hitachi) Reagent HEX
Recall of Glucose Hexokinase (Hitachi) Reagent (HEX)
Recall of Pointe Scientific Glucose Hexokinase (Hitachi) Reagent
Recall of Pointe Scientific Glucose Hexokinase (Hitachi) Reagent HEX
Recall of Pointe Scientific Glucose Hexokinase (Hitachi) Reagent HEX R2
Recall of Pointe Scientific Glucose Hexokinase (Hitachi) Reagent (HEX) R1
Recall of Device Recall Pointe Scientific Uric Acid (Liquid) Reagent Set
Recall of Device Recall Pointe Scientific Uric Acid (Liquid) Reagent Set
Recall of Device Recall Pointe Scientific Creatinine Reagent R2
Recall of Device Recall Pointe Scientific Creatinine Reagent Set
Recall of Device Recall Pointe Scientific Iron Reagent (R2)
Recall of Device Recall Pointe Scientific Iron Color Reagent
Recall of Device Recall Pointe Scientific Iron Buffer Reagent
Recall of Device Recall Pointe Scientific Iron (Ferrozine) R2 Reagent Set
Recall of Device Recall Pointe Scientific Iron (Ferrozine) R1 Reagent Set
Recall of Device Recall Pointe Scientific Iron (Ferrozine) Reagent Set
Recall of Device Recall Pointe Scientific Total Iron Reagent Set
Recall of Device Recall Pointe Scientific Iron/TIBC Reagent Set
Recall of Device Recall Liquid HDL (PEG) Cholesterol Reagent
Recall of Device Recall Liquid HDL (PEG) Cholesterol Reagent Set
Recall of Device Recall Pointe Scientific Liquid Hitachi Calcium Reagent Set
Recall of Device Recall Pointe Scientific Liquid Hitachi Calcium Reagent Set
Recall of Device Recall Pointe Scientific Liquid Hitachi Calcium Reagent Set
Recall of Device Recall Pointe Scientific Direct Bilirubin Reagent Set
Recall of Device Recall AUTOHDL CHOLESTEROL REAGENT SET
Recall of Device Recall AUTOHDL CHOLESTEROL REAGENT SET
Recall of Device Recall HITACHI DIRECT AND HITACHI TOTAL BILIRUBIN REAGENT
Recall of Device Recall Pointe Scientific Glucose Oxidase Reagent
Recall of Device Recall Liquid Alkaline Phosphatase Reagent Set
Recall of Device Recall Liquid Alkaline Phosphatase Reagent Set
Recall of Device Recall Liquid Alkaline Phosphatase Reagent Set
Recall of Device Recall Liquid Alkaline Phosphatase Reagent
Recall of Device Recall Liquid Alkaline Phosphatase Reagent
Recall of Device Recall Liquid Alkaline Phosphatase Reagent
Recall of Device Recall Liquid Alkaline Phosphatase Reagent
Recall of Device Recall Liquid Alkaline Phosphatase Reagent
Recall of Device Recall Liquid ALT
Recall of Device Recall Liquid ALT
Recall of Device Recall Liquid ALT
Recall of Device Recall Liquid ALT
Recall of Device Recall Liquid ALT
Recall of Device Recall Liquid ALT
Recall of Device Recall Liquid ALT
Recall of Device Recall Liquid ALT
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36 devices in the database
Pointe Scientific Liquid Glucose (HEXO) Reagent Set
Model / Serial
All lots beginning with the numbers 814301, 820502, 823901, 826801, 829401, 814301, 820502, and 831502.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Israel, Mexico, South Africa, and West Indies.
Product Description
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry) || Pointe Scientific Liquid Glucose (HEXO) is used for the quantitative determination of glucose in serum.
Glucose Hexokinase (Hitachi) Reagent HEX
Model / Serial
Lots 727501-008 and 727501-233.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Canada, China, Romania and Trinidad.
Product Description
Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)
Glucose Hexokinase (Hitachi) Reagent (HEX)
Model / Serial
Lot 727501.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Canada, China, Romania and Trinidad.
Product Description
Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
Pointe Scientific Glucose Hexokinase (Hitachi) Reagent
Model / Serial
HG920-1200 lots 727501-021 and 727501-203; HG920-2500 lot 727501-015; and 12-HG920-144 lots 727501-080 and 727501-142..
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Canada, China, Romania and Trinidad.
Product Description
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG920-1200, HG920-2500 and 12-HG920-144. (Clinical chemistry)
Pointe Scientific Glucose Hexokinase (Hitachi) Reagent HEX
Model / Serial
HG720-600 lots 727501-303, 727501-355 and 727501-127. HG920-756 lot 727501-112.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Canada, China, Romania and Trinidad.
Product Description
Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG720-600 and HG920-756. (Clinical chemistry)
31 more
One manufacturer with a similar name
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Pointe Scientific, Inc.
Manufacturer Address
Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
Manufacturer Parent Company (2017)
Medtest Holdings Inc
Source
USFDA
Language
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