Lumipulse G pTau 217 Plasma Immunoreaction Cartridges

GUDID 05414470815500

Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 3x14T, IVD-US

Fujirebio Europe

Tau protein IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 05414470815500
• NIH Device Record Key: 0c79d7cd-5f30-4d7b-908b-4bd4aebeda46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
• Version Model Number: 81550
• Company DUNS: 297346645
• Company Name: Fujirebio Europe
• 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: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414470815500 [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: 2025-06-24
• Device Publish Date: 2025-06-16

Devices Manufactured by Fujirebio Europe

• 05414470815500 - Lumipulse G pTau 217 Plasma Immunoreaction Cartridges: 2025-06-24Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 3x14T, IVD-US
• 05414470815500 - Lumipulse G pTau 217 Plasma Immunoreaction Cartridges: 2025-06-24 Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 3x14T, IVD-US
• 05414470815579 - Lumipulse G pTau 217 Plasma Calibrators: 2025-06-24 Lumipulse G pTau 217 Plasma Calibrators 1x5C, IVD-US
• 05414470815586 - Lumipulse pTau 217 Plasma Controls: 2025-06-24 Lumipulse pTau 217 Plasma Controls 2x2C, IVD-US
• 05414470815593 - Lumipulse B-Amyloid Plasma Controls: 2025-06-24 Lumipulse B-Amyloid Plasma Controls 2x2C, IVD-US
• 05414470156870 - LiRAS for LiPA HCV v1: 2025-06-09
• 05414470816590 - INNO-LiPA HCV 2.0 Genotyping: 2025-06-09
• 05414470816606 - INNO-LiPA HCV 2.0 Amp: 2025-06-09
• 05414470816613 - INNO-LiPA HCV 2.0 Control: 2025-06-09