Catalog Number

01-05-0015

Brand Name

Trinity Biotech

Version/Model Number

Resolution Analytical Column

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)

-

FDA Premarket Submission

K955283

Product Code

GKA

Product Code Name

Abnormal Hemoglobin Quantitation

Public Device Record Key

bdb9f2b3-6b60-4e1a-b300-3dab769b3d4a

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-