Catalog Number

G5-203S50

Brand Name

INFINITY™ Test Strips

Version/Model Number

IGM-0024

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082201,K082201

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

1815c211-0b92-439c-b276-3371eb8a4787

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 13, 2017

Package DI Number

00885502002000

Quantity per Package

2

Contains DI Package

10885502002007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-