Catalog Number

5401640190

Brand Name

Tinaquant Hemoglobin A1c Gen2 Whole blood and Hemolysate Application

Version/Model Number

5401640190

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

K072714

Product Code

LCP

Product Code Name

ASSAY, GLYCOSYLATED HEMOGLOBIN

Public Device Record Key

ec1769bf-6320-4e13-bde1-02e8f6161219

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-