AccessGUDID - DEVICE: Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges (04987270231432)

GUDID

Device Identifier (DI) Information

Brand Name: Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges
Version or Model: 231432
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIREBIO INC.

Primary DI Number: 04987270231432
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 710873907 *Terms of Use

Device Description: No description.

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?
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
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN200072	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
Handling Environment Temperature: between 1 and 10 Degrees Celsius
Storage Environment Temperature: between 2 and 10 Degrees Celsius
Special Storage Condition, Specify: right side up with care. No vibration.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Number of tests per kit: 42

Device Record Status

Public Device Record Key: 69d1e382-f666-4611-bdef-1760dd2e3178
Public Version Date: October 10, 2024
Public Version Number: 6
DI Record Publish Date: November 10, 2022