Catalog Number

IGM-G3-203

Brand Name

Control™ Test Strips

Version/Model Number

IGM-0009

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

K043543,K043543

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

cf0b0987-278b-4d1a-a431-012aa8f364b9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 26, 2017

Package DI Number

00885502002048

Quantity per Package

2

Contains DI Package

10885502002045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-