Elecsys Anti-HCV Immunoassay

Basic Information

• Brand Name: Elecsys Anti-HCV Immunoassay
• Primary DI: 04015630919260
• Version / Model: 03290352160
• Catalog Number: 03290352160
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-11
• Public Version: 3
• Public Version Date: 2020-11-26
• Public Version Status: Update
• Public Device Record Key: 2633c715-0a99-4d86-9e99-21dd179e3383
• Distribution End Date: 2018-10-08

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
MZO	ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS	Unknown		2

GMDN Terms

Code	Name	Definition	Implantable	Status
48352	Hepatitis C virus antigen IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis C virus antigens in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630919260	GS1

Storage Conditions

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