Catalog Number

01-04-0022

Brand Name

Trinity Biotech

Version/Model Number

HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

Yes

FDA Premarket Submission

K112015

Product Code

JPK

Product Code Name

Mixture, Hematology Quality Control

Public Device Record Key

573eebaf-c2d2-49af-b5a2-0554c95e2feb

Public Version Date

August 29, 2022

Public Version Number

5

DI Record Publish Date

September 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-