Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges

GUDID 04987270231753

FUJIREBIO INC.

Amyloid B component IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04987270231753
• NIH Device Record Key: 1c0f5552-bdfe-4acc-823c-9d4353668e23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges
• Version Model Number: 231753
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

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Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care. No vibration.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270231753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200072

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: 2022-03-22
• Device Publish Date: 2022-03-14

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• 04987270234891 - Lumipulse G B-Amyloid 1-40 Calibrator Set: 2022-11-08
• 04987270234907 - Lumipulse B-Amyloid Controls: 2022-11-08
• 04987270230343 - Lumipulse G B-Amyloid 1-42 Immunoreaction Calibrator Set: 2022-03-22
• 04987270231432 - Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges: 2022-03-22
• 04987270231531 - Lumipulse G B-Amyloid 1-40 Calibrator Set: 2022-03-22