Catalog Number

3S-01-16003C

Brand Name

GL GoodLife AC300 Test Strip-Vial

Version/Model Number

AC-11 vial

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113307,K113307

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

a289a2b6-7da4-435f-a929-f5645822b4c1

Public Version Date

August 09, 2019

Public Version Number

5

DI Record Publish Date

November 17, 2016

Package DI Number

00389154000587

Quantity per Package

400

Contains DI Package

00389154000570

Package Discontinue Date

December 31, 2018

Package Status

Not in Commercial Distribution

Package Type

-