Lumipulse G B-Amyloid 1-42-N Plasma

GUDID 04987270235447

Lumipulse G B-Amyloid 1-42-N Plasma IRC

FUJIREBIO INC.

Tau protein IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04987270235447
• NIH Device Record Key: a06f655f-c61a-4ff8-99be-525a528f4b46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumipulse G B-Amyloid 1-42-N Plasma
• Version Model Number: 235447
• Company DUNS: 710873907
• Company Name: FUJIREBIO INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com
• Phone: 610-240-3800
• Email: customersupport.us@fujirebio-us.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270235447 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-14
• Device Publish Date: 2025-01-06

Devices Manufactured by FUJIREBIO INC.

• 04987270235447 - Lumipulse G B-Amyloid 1-42-N Plasma: 2025-01-14Lumipulse G B-Amyloid 1-42-N Plasma IRC
• 04987270235447 - Lumipulse G B-Amyloid 1-42-N Plasma: 2025-01-14 Lumipulse G B-Amyloid 1-42-N Plasma IRC
• 04987270235454 - Lumipulse G B-Amyloid 1-42-N Plasma Calibrator: 2025-01-14 Lumipulse G B-Amyloid 1-42-N Plasma Calibrator
• 04987270235485 - Lumipulse G B-Amyloid Controls (Plasma)-N: 2025-01-14 Lumipulse G B-Amyloid Controls (Plasma)-N
• 04987270234938 - Lumipulse G BRAHMS PCT Calibrator Set: 2023-05-04
• 04987270234945 - Lumipulse BRAHMS PCT Controls: 2023-05-04
• 04987270234884 - Lumipulse G B-Amyloid 1-42 Immunoreaction Calibrator Set: 2022-11-08
• 04987270234891 - Lumipulse G B-Amyloid 1-40 Calibrator Set: 2022-11-08
• 04987270234907 - Lumipulse B-Amyloid Controls: 2022-11-08