Catalog Number

42214

Brand Name

StatStrip

Version/Model Number

GLU Test Strip

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

Yes

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

-

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

de61e694-6fe5-4ea7-b56a-7dda78dabf64

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

December 26, 2017

Package DI Number

20385480422141

Quantity per Package

2

Contains DI Package

10385480422144

Package Discontinue Date

-

Package Status

-

Package Type

Carton