INNO-LiPA HCV 2.0 Amp

GUDID 05414470816637

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

Primary Device ID	05414470816637
NIH Device Record Key	d1f9da85-a01b-45ca-af5d-ff54f3f52108
Commercial Distribution Status	In Commercial Distribution
Brand Name	INNO-LiPA HCV 2.0 Amp
Version Model Number	81663
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

Storage Environment Temperature	Between -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and -15 Degrees Celsius

Device Issuing Agency	Device ID
GS1	05414470816637 [Primary]

OBF	Assay, Genotyping, Hepatitis C Virus

Steralize Prior To Use	false
Device Is Sterile	false

05414470816637	81663
05414470816606	81660