LiRAS for LiPA HCV v1

GUDID 05414470156870

Fujirebio Europe

Laboratory instrument/analyser application software IVD

• Primary Device ID: 05414470156870
• NIH Device Record Key: 73aec945-6602-466d-a4d8-cd6a803af344
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LiRAS for LiPA HCV v1
• Version Model Number: 15687
• 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: false
• 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: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The production identifier of this product is the software identification
• Special Storage Condition, Specify: Between 0 and 0 *The production identifier of this product is the software identification
• Special Storage Condition, Specify: Between 0 and 0 *The production identifier of this product is the software identification

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414470156870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160016

FDA Product Code

• OBF: Assay, Genotyping, Hepatitis C Virus

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: 2025-06-09
• Device Publish Date: 2025-05-30

Devices Manufactured by Fujirebio Europe

• 05414470156870 - LiRAS for LiPA HCV v1: 2025-06-09
• 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
• 05414470816620 - INNO-LiPA HCV 2.0 Genotyping: 2025-06-09
• 05414470816637 - INNO-LiPA HCV 2.0 Amp: 2025-06-09
• 05414470804214 - TENDIGO Disposable Trays: 2022-09-22 Disposable Trays 5 trays per base unit
• 05414470804122 - TENDIGO: 2020-03-03 Instrument