INNO-LiPA HCV 2.0 Genotyping

GUDID 05414470816590

Fujirebio Europe

Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 05414470816590
• NIH Device Record Key: 5fc61839-563d-4453-a2b9-684d7c3530ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNO-LiPA HCV 2.0 Genotyping
• Version Model Number: 81659
• 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
• 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
• 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
• 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
• 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	05414470816590 [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

On-Brand Devices [INNO-LiPA HCV 2.0 Genotyping]

• 05414470816620: 81662
• 05414470816590: 81659