AccessGUDID - DEVICE: LIAISON QUANTIferon TB Gold Plus (08056771602945)

GUDID

Device Identifier (DI) Information

Brand Name: LIAISON QUANTIferon TB Gold Plus
Version or Model: 311020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Diasorin Inc.

Primary DI Number: 08056771602945
Issuing Agency: GS1
Commercial Distribution End Date: March 25, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 033429783 *Terms of Use

Device Description: USA manufactured 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):	No
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?
63758	Pregnenolone IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of pregnenolone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used as an aid in the diagnosis of adrenal hyperplasia and hirsutism.	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: 75ed3b24-1292-41f5-b960-44f71d577242
Public Version Date: March 26, 2025
Public Version Number: 2
DI Record Publish Date: September 08, 2023