Elecsys PreciControl Anti-HCV

Basic Information

• Brand Name: Elecsys PreciControl Anti-HCV
• Primary DI: 04015630919277
• Version / Model: 03290379160
• Catalog Number: 03290379160
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-12-18
• Public Version: 3
• Public Version Date: 2018-10-01
• Public Version Status: Update
• Public Device Record Key: 310385a5-fdd6-4edc-a905-18472b44aa18
• Distribution End Date: 2018-09-30

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
41973	Hepatitis C virus total antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis C virus in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630919277	GS1

Storage Conditions

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