Duns Number:008675485
Device Description: QFT-Plus High Altitiude Blood Collection Tubes (50x)
Catalog Number
623536
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
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
14b2d7e6-3a5b-484f-b5c3-7c52c746bc17
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
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| 3 | A medical device with high risk that requires premarket approval | 11 |