Catalog Number

400K-100X

Brand Name

Trinity Biotech

Version/Model Number

400K-100X

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JBG

Product Code Name

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot

Public Device Record Key

9fe91ef8-293c-4b02-b83c-6d13343fad59

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-