Catalog Number

-

Brand Name

Trinity Biotech

Version/Model Number

827402

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

K935413

Product Code

LLL

Product Code Name

Extractable Antinuclear Antibody, Antigen And Control

Public Device Record Key

312045df-19df-4b47-a142-00e1fb0a19bc

Public Version Date

January 06, 2020

Public Version Number

1

DI Record Publish Date

December 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-