Lumipulse B-Amyloid Controls

Basic Information

• Brand Name: Lumipulse B-Amyloid Controls
• Primary DI: 04987270234907
• Version / Model: 234907
• Company Name: FUJIREBIO INC.
• Labeler DUNS: 710873907
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-31
• Public Version: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 6444506d-236d-4532-9835-51f06a812e82

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
56782	Amyloid B component IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of amyloid B component in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987270234907	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN200072	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Number of bottles per kit: 7
Device Size Text, specify			Total mLs per bottle: 10

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Right side up with care. No vibration.