Catalog Number

3L-10-160032

Brand Name

GoodLife foil packed test strip

Version/Model Number

3L-10-160032

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

K113307,K113307

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

35ac625a-68d6-4773-940d-86d004bad379

Public Version Date

January 15, 2021

Public Version Number

1

DI Record Publish Date

January 07, 2021

Package DI Number

04711200723069

Quantity per Package

120

Contains DI Package

04711200721034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Foil