ADVIA Centaur® Systems HCV QC

Basic Information

• Brand Name: ADVIA Centaur® Systems HCV QC
• Primary DI: 00630414473178
• Version / Model: 10309062
• Catalog Number: 3439141
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 5
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: 0c6e2424-1fbb-4863-b72c-35f566bebecf

Device Description

HCV(aHCV) Quality Control Material Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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	00630414473178	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store Upright, Protect from Light, Do not freeze, Resuspend.