cobas¿ HCV Quantitative nucleic acid test for use on the cobas¿ 68008800 System 06998798190

GUDID 00875197004694

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

Primary Device ID	00875197004694
NIH Device Record Key	b2a92d34-9a12-4f44-ad96-5d87d11083c9
Commercial Distribution Status	In Commercial Distribution
Brand Name	cobas¿ HCV Quantitative nucleic acid test for use on the cobas¿ 68008800 System
Version Model Number	6998798190
Catalog Number	06998798190
Company DUNS	315028860
Company Name	Roche Diagnostics GmbH
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	true
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	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00875197004694 [Primary]

MZP	ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

Steralize Prior To Use	false
Device Is Sterile	false