Catalog Number

03-01-0052

Brand Name

Trinity Biotech

Version/Model Number

Ultra2 Affinity HbA1c Analyzer (110V)

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

K891235

Product Code

LCP

Product Code Name

Assay, Glycosylated Hemoglobin

Public Device Record Key

a6098cbb-36b6-4ff6-8a1c-8dfe0d4ea941

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-