Catalog Number

-

Brand Name

GlucoTrack Blood Glucose Test Strips

Version/Model Number

GT-S01

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

K141656,K150299,K151658,K131230,K113636,K113636,K131230,K141656,K150299,K151658,K131230,K141656,K150299,K151658,K113636

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

876c1627-aa37-4129-bcea-02c6a3db94ac

Public Version Date

September 17, 2018

Public Version Number

1

DI Record Publish Date

August 16, 2018

Package DI Number

08809301168028

Quantity per Package

2

Contains DI Package

08809301168011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-