QuantiFERON®-TB Gold Plus 622529

GUDID 14053228033568

QFT-Plus Blood Collection Tubes (1200x)

QIAGEN SCIENCES INC.

T-cell activation/stimulated interferon release IVD, reagent
Primary Device ID14053228033568
NIH Device Record Keyce12f14d-dab9-4071-9366-2247388b3dad
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantiFERON®-TB Gold Plus
Version Model Number1
Catalog Number622529
Company DUNS008675485
Company NameQIAGEN SCIENCES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS114053228033568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NCDTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-26
Device Publish Date2019-12-18

On-Brand Devices [QuantiFERON®-TB Gold Plus]

04053228015871QFT-Plus Reference Lab Pack Elisa Kit
04053228015864QFT-Plus 2 Plate Elisa Kit
14053228015915QFT-Plus High Altitiude Blood Collection Tubes (25x)
14053228015908QFT-Plus High Altitiude Blood Collection Tubes (50x)
14053228015892QFT-Plus Blood Collection Tubes (50x)
14053228015885QFT-Plus Blood Collection Tubes (25x)
14053228033575QFT-Plus High Altitude Blood Collection Tubes (1200x)
14053228033568QFT-Plus Blood Collection Tubes (1200x)

Trademark Results [QuantiFERON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUANTIFERON
QUANTIFERON
74614094 2053838 Live/Registered
CELLESTIS LIMITED
1994-12-22

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