Glucose (HK) - For in vitro diagnostic use in the quantitative - Thermo Fisher Scientific Oy

Duns Number:540096708

Device Description: For in vitro diagnostic use in the quantitative determination of the glucose concentration For in vitro diagnostic use in the quantitative determination of the glucose concentration in human serum, plasma or urine on Konelab and Indiko analyzers.

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More Product Details

Catalog Number

981779

Brand Name

Glucose (HK)

Version/Model Number

NONE

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110035

Product Code Details

Product Code

CFR

Product Code Name

Hexokinase, Glucose

Device Record Status

Public Device Record Key

2cc2a908-554b-4e89-93c3-e6ead88eb4fc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERMO FISHER SCIENTIFIC OY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6