Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740131364
• Version / Model: 08P2710
• Catalog Number: 08P2710
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-06
• Public Version: 1
• Public Version Date: 2020-11-16
• Public Version Status: New
• Public Device Record Key: b7383470-4f62-4d75-9032-eef92a6b91a3

Device Description

Alinity i HAVAb IgG Controls

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
MJX	Kit, serological, positive control	Clinical Chemistry	862.1660	1
MJY	Kit, serological, negative control	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41985	Hepatitis B virus core antigen IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus core antigen in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740131364	GS1

Customer Contacts

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

Storage Conditions

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