INNO-LiPA HCV 2.0 Genotyping

Basic Information

• Brand Name: INNO-LiPA HCV 2.0 Genotyping
• Primary DI: 05414470816620
• Version / Model: 81662
• Company Name: Fujirebio Europe
• Labeler DUNS: 297346645
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-30
• Public Version: 2
• Public Version Date: 2025-09-23
• Public Version Status: Update
• Public Device Record Key: a45c853d-7449-4cd3-98e9-c93f42ef94c3
• Distribution End Date: 2025-05-30

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBF	Assay, Genotyping, Hepatitis C Virus	Microbiology	866.3170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59866	Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the genotype determination of Hepatitis C virus in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414470816620	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P160016	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Number of tests per kit = 100

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius