Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

GUDID 00869164000086

Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Fujirebio Diagnostics, Inc.

Tau protein IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00869164000086
• NIH Device Record Key: c710bd2b-6ac2-41b1-98f0-a4507bc71a7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
• Version Model Number: CL0073
• Company DUNS: 048524263
• Company Name: Fujirebio Diagnostics, 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869164000086 [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: 2024-11-12
• Device Publish Date: 2024-11-04

Devices Manufactured by Fujirebio Diagnostics, Inc.

• 00869164000086 - Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio: 2024-11-12Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
• 00869164000086 - Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio: 2024-11-12 Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
• 00869164000055 - Serodia TP-PA Kits: 2023-12-14 100 test kit
• 00869164000062 - Serodia TP-PA Kits: 2023-12-14 220 test kits
• 00869164000079 - Emit Cyclosporine Sample: 2023-12-14
• 00869164000048 - Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool: 2022-03-22 Software
• 00869164000000 - MESOMARK: 2018-07-06
• 00869164000017 - Lumipulse G ROMA: 2018-07-06 Software Disk
• 00869164000024 - ROMA: 2018-07-06 ROMA (HE4 EIA + ARCHITECT CA125II) Software disk