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

GUDID 04987270235454

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

FUJIREBIO INC.

Tau protein IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04987270235454
• NIH Device Record Key: da15577d-aa51-428a-9e50-3fc8d55cfabf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumipulse G B-Amyloid 1-42-N Plasma Calibrator
• Version Model Number: 235454
• 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
• 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
• 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
• 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

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Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270235454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242706

FDA Product Code

• SET: Immunoassay Blood Test For Amyloid Pathology Assessment

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

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• 04987270235454 - Lumipulse G B-Amyloid 1-42-N Plasma Calibrator: 2025-01-14Lumipulse G B-Amyloid 1-42-N Plasma Calibrator
• 04987270235454 - Lumipulse G B-Amyloid 1-42-N Plasma Calibrator: 2025-01-14 Lumipulse G B-Amyloid 1-42-N Plasma Calibrator
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• 04987270234891 - Lumipulse G B-Amyloid 1-40 Calibrator Set: 2022-11-08