Trinity Biotech - Hemoglobin A1c assay, HbA1c (GHb) Controls Kit, - PRIMUS CORPORATION

Duns Number:790074793

Device Description: Hemoglobin A1c assay, HbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 1 kit

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More Product Details

Catalog Number

01-04-0020

Brand Name

Trinity Biotech

Version/Model Number

HbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 1 kit

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

JPK

Product Code Name

Mixture, Hematology Quality Control

Device Record Status

Public Device Record Key

e906fcf2-6a69-48bb-b943-4f13b5fe5cb9

Public Version Date

August 29, 2022

Public Version Number

5

DI Record Publish Date

September 06, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRIMUS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 52