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Crédits
Manufacturers
Pointe Scientific, Inc.
Adresse du fabricant
Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188
Société-mère du fabricant (2017)
MedTest Holdings
Source
USFDA
45 Events
Rappel de Pointe Scientific Liquid Glucose (HEXO) Reagent Set
Rappel de Glucose Hexokinase (Hitachi) Reagent HEX
Rappel de Glucose Hexokinase (Hitachi) Reagent (HEX)
Rappel de Pointe Scientific Glucose Hexokinase (Hitachi) Reagent
Rappel de Pointe Scientific Glucose Hexokinase (Hitachi) Reagent HEX
Rappel de Pointe Scientific Glucose Hexokinase (Hitachi) Reagent HEX R2
Rappel de Pointe Scientific Glucose Hexokinase (Hitachi) Reagent (HEX) R1
Rappel de Device Recall Pointe Scientific Uric Acid (Liquid) Reagent Set
Rappel de Device Recall Pointe Scientific Uric Acid (Liquid) Reagent Set
Rappel de Device Recall Pointe Scientific Creatinine Reagent R2
Rappel de Device Recall Pointe Scientific Creatinine Reagent Set
Rappel de Device Recall Pointe Scientific Iron Reagent (R2)
Rappel de Device Recall Pointe Scientific Iron Color Reagent
Rappel de Device Recall Pointe Scientific Iron Buffer Reagent
Rappel de Device Recall Pointe Scientific Iron (Ferrozine) R2 Reagent Set
Rappel de Device Recall Pointe Scientific Iron (Ferrozine) R1 Reagent Set
Rappel de Device Recall Pointe Scientific Iron (Ferrozine) Reagent Set
Rappel de Device Recall Pointe Scientific Total Iron Reagent Set
Rappel de Device Recall Pointe Scientific Iron/TIBC Reagent Set
Rappel de Device Recall Liquid HDL (PEG) Cholesterol Reagent
Rappel de Device Recall Liquid HDL (PEG) Cholesterol Reagent Set
Rappel de Device Recall Pointe Scientific Liquid Hitachi Calcium Reagent Set
Rappel de Device Recall Pointe Scientific Liquid Hitachi Calcium Reagent Set
Rappel de Device Recall Pointe Scientific Liquid Hitachi Calcium Reagent Set
Rappel de Device Recall Pointe Scientific Direct Bilirubin Reagent Set
Rappel de Device Recall AUTOHDL CHOLESTEROL REAGENT SET
Rappel de Device Recall AUTOHDL CHOLESTEROL REAGENT SET
Rappel de Device Recall HITACHI DIRECT AND HITACHI TOTAL BILIRUBIN REAGENT
Rappel de Device Recall Pointe Scientific Glucose Oxidase Reagent
Rappel de Device Recall Liquid Alkaline Phosphatase Reagent Set
Rappel de Device Recall Liquid Alkaline Phosphatase Reagent Set
Rappel de Device Recall Liquid Alkaline Phosphatase Reagent Set
Rappel de Device Recall Liquid Alkaline Phosphatase Reagent
Rappel de Device Recall Liquid Alkaline Phosphatase Reagent
Rappel de Device Recall Liquid Alkaline Phosphatase Reagent
Rappel de Device Recall Liquid Alkaline Phosphatase Reagent
Rappel de Device Recall Liquid Alkaline Phosphatase Reagent
Rappel de Device Recall Liquid ALT
Rappel de Device Recall Liquid ALT
Rappel de Device Recall Liquid ALT
Rappel de Device Recall Liquid ALT
Rappel de Device Recall Liquid ALT
Rappel de Device Recall Liquid ALT
Rappel de Device Recall Liquid ALT
Rappel de Device Recall Liquid ALT
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36 dispositifs dans la base de données
Pointe Scientific Liquid Glucose (HEXO) Reagent Set
Modèle / numéro de série
All lots beginning with the numbers 814301, 820502, 823901, 826801, 829401, 814301, 820502, and 831502.
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution -- USA, Israel, Mexico, South Africa, and West Indies.
Description du dispositif
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
Modèle / numéro de série
Lots 727501-008 and 727501-233.
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide, Canada, China, Romania and Trinidad.
Description du dispositif
Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)
Glucose Hexokinase (Hitachi) Reagent (HEX)
Modèle / numéro de série
Lot 727501.
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide, Canada, China, Romania and Trinidad.
Description du dispositif
Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
Pointe Scientific Glucose Hexokinase (Hitachi) Reagent
Modèle / numéro de série
HG920-1200 lots 727501-021 and 727501-203; HG920-2500 lot 727501-015; and 12-HG920-144 lots 727501-080 and 727501-142..
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide, Canada, China, Romania and Trinidad.
Description du dispositif
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
Modèle / numéro de série
HG720-600 lots 727501-303, 727501-355 and 727501-127. HG920-756 lot 727501-112.
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide, Canada, China, Romania and Trinidad.
Description du dispositif
Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG720-600 and HG920-756. (Clinical chemistry)
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Pointe Scientific, Inc.
Adresse du fabricant
Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
Société-mère du fabricant (2017)
Medtest Holdings Inc
Source
USFDA
Language
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