Catalog Number

07559674190

Brand Name

Tina-quant Hemoglobin A1cDx Gen.3

Version/Model Number

07559674190

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160571

Product Code

PDJ

Product Code Name

Hemoglobin A1c test system

Public Device Record Key

d4d53c45-6549-4f51-9186-76cda4b80898

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-