AccessGUDID - DEVICE: LIAISON Control QUANTIferon TB Gold Plus (08056771602952)

GUDID

Device Identifier (DI) Information

Brand Name: LIAISON Control QUANTIferon TB Gold Plus
Version or Model: 311021
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Diasorin Inc.

Primary DI Number: 08056771602952
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033429783 *Terms of Use

Device Description: USA manufactured control kit

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60746	Interferon gamma release IVD, control	A material which is used to verify the performance of an assay intended to be 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NCD	Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e205cf0e-f0bf-4c95-a125-b44f77e68a63
Public Version Date: September 18, 2023
Public Version Number: 1
DI Record Publish Date: September 08, 2023