Catalog Number

-

Brand Name

BLE Smart Test Strip

Version/Model Number

BLE-SMART-TS50-FDA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2020

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

061cb1b2-5820-476b-b14d-6ba59517ca2a

Public Version Date

October 28, 2021

Public Version Number

2

DI Record Publish Date

February 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-