QuantiFERON®-TB Gold Plus

Basic Information

• Brand Name: QuantiFERON®-TB Gold Plus
• Primary DI: 14053228033568
• Version / Model: 1
• Catalog Number: 622529
• Company Name: QIAGEN SCIENCES INC.
• Labeler DUNS: 008675485
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-18
• Public Version: 2
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: ce12f14d-dab9-4071-9366-2247388b3dad

Device Description

QFT-Plus Blood Collection Tubes (1200x)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NCD	Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60747	Interferon gamma release IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of interferon gamma (IFN gamma) released in response to T-cell activation resulting from stimulation by one or multiple specific antigens or mitogens, including (but not limited to) B Borrelia species, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), BK virus, severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), and/or Mycobacterium species.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14053228033568	GS1

Premarket Submissions

Submission Number	Supplement Number
P010033	000