AccessGUDID - DEVICE: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (05414470815500)

GUDID

Device Identifier (DI) Information

Brand Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
Version or Model: 81550
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fujirebio Europe

Primary DI Number: 05414470815500
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 297346645 *Terms of Use

Device Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 3x14T, IVD-US

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:	Yes
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?
65902	Tau protein IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of microtubule-associated tau protein [total tau (t-tau) or phosphorylated tau (p-tau)] in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid the diagnosis of neurodegenerative disorders such as Alzheimer's disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SET	Immunoassay Blood Test For Amyloid Pathology Assessment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242706	000

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 42 Tests per kit

Device Record Status

Public Device Record Key: 0c79d7cd-5f30-4d7b-908b-4bd4aebeda46
Public Version Date: June 24, 2025
Public Version Number: 1
DI Record Publish Date: June 16, 2025