Pointe Scientific, Inc. GGT - Gamma glutamyl transferase Reagent is for the - Medtest Dx, Inc.

Duns Number:070371210

Device Description: Gamma glutamyl transferase Reagent is for the quantitative kinetic determination of gamma Gamma glutamyl transferase Reagent is for the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum on Hitachi analyzers. For in vitro diagnostic use only. 1 x 1L, 1 x 400ml

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More Product Details

Catalog Number

HG959-1400

Brand Name

Pointe Scientific, Inc. GGT

Version/Model Number

HG959-1400

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

K973157

Product Code Details

Product Code

JQB

Product Code Name

Kinetic Method, Gamma-Glutamyl Transpeptidase

Device Record Status

Public Device Record Key

e9145899-e96b-45d6-8041-a00ab32d23f7

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

-

"MEDTEST DX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 33