AccessGUDID - DEVICE: QuantiFERON-TB Gold Blood Collection Tubes (14053228002144)

GUDID

Device Identifier (DI) Information

Brand Name: QuantiFERON-TB Gold Blood Collection Tubes
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T05900301
Company Name: QIAGEN SCIENCES INC.

Primary DI Number: 14053228002144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 008675485 *Terms of Use

Device Description: Bulk pack

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:	Yes
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?
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.	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 [?]
P010033	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: 9f46c6bd-0ad3-4d22-a558-e90a2e7e680d
Public Version Date: October 29, 2021
Public Version Number: 4
DI Record Publish Date: January 04, 2017