Catalog Number

622832

Brand Name

QuantiFERON®-TB Gold Plus

Version/Model Number

1

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

P010033

Product Code

NCD

Product Code Name

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Public Device Record Key

b386ac0c-4130-4e82-8270-a7055aad010e

Public Version Date

March 08, 2022

Public Version Number

5

DI Record Publish Date

October 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-