Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740131067
• Version / Model: 08P5001
• Catalog Number: 08P5001
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-03
• Public Version: 4
• Public Version Date: 2024-02-21
• Public Version Status: Update
• Public Device Record Key: f1696113-7156-4766-a2e8-eefc9431f7a7

Device Description

Alinity i HE4 Calibrators

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
JIT	Calibrator, secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56658	Human epididymis protein 4 (HE4) 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 human epididymis protein 4 (HE4) ovarian cancer marker, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740131067	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius