Pointe Scientific, Inc. Glucose Standard - Reagent intended for use as an glucose standard - POINTE SCIENTIFIC, INC.

Duns Number:045623154

Device Description: Reagent intended for use as an glucose standard for standardization or calibration of glu Reagent intended for use as an glucose standard for standardization or calibration of glucose hexokinase or oxidase procedures.1 x 100 mg/dl

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More Product Details

Catalog Number

13-G7518-STD

Brand Name

Pointe Scientific, Inc. Glucose Standard

Version/Model Number

13-G7518-STD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K810674

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

de3dc1a3-18d9-432b-a688-76e4fdfc8c09

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POINTE SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 455
U Unclassified 2