Catalog Number

GLU2-1L

Brand Name

JAS Diagnostics

Version/Model Number

GLU2-1L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K011900

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

5ec41ee8-fc3e-4235-8e1f-0f7208117cfd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-