AccessGUDID - DEVICE: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio (00869164000086)

GUDID

Device Identifier (DI) Information

Brand Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Version or Model: CL0073
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fujirebio Diagnostics, Inc.

Primary DI Number: 00869164000086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 048524263 *Terms of Use

Device Description: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

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:	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
65218	Amyloid B component IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of amyloid B component, also known as amyloid beta or Aß, in a clinical specimen, using a chemiluminescent immunoassay method. It is used to aid the diagnosis of 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c710bd2b-6ac2-41b1-98f0-a4507bc71a7e
Public Version Date: June 19, 2025
Public Version Number: 4
DI Record Publish Date: November 04, 2024