Catalog Number

K3105B

Brand Name

Dimension Vista System Flex reagent cartridge A1C KIT

Version/Model Number

10720885

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173909

Product Code

PDJ

Product Code Name

Hemoglobin A1c test system

Public Device Record Key

8e76ee1e-adab-40ff-ac82-3c6baf7f2a9c

Public Version Date

November 18, 2021

Public Version Number

4

DI Record Publish Date

February 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-