Catalog Number

-

Brand Name

LIAISON® QuantiFERON® Software

Version/Model Number

Q0001

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

-

Product Code

NCD

Product Code Name

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Public Device Record Key

0ddb3a15-5d67-47b6-a8d7-7cc22ffbdb63

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

December 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-