Catalog Number

5970405

Brand Name

QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - High Altitude

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

Yes

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,P010033

Product Code

NCD

Product Code Name

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Public Device Record Key

951c7ef0-b591-45ac-a36d-bd3293a3bdb3

Public Version Date

October 29, 2021

Public Version Number

4

DI Record Publish Date

January 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-