Catalog Number

-

Brand Name

microdot Blood Glucose Test Strips

Version/Model Number

100-50

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

K070524,K070524,K070524

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

1eb69ab4-9898-47c4-9290-2413a3196314

Public Version Date

April 12, 2022

Public Version Number

1

DI Record Publish Date

April 04, 2022

Package DI Number

35060141250036

Quantity per Package

150

Contains DI Package

05060141250592

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack