Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740194864
• Version / Model: 04W1710
• Catalog Number: 04W1710
• Company Name: Abbott Ireland Diagnostics
• Labeler DUNS: 985307301
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-11
• Public Version: 1
• Public Version Date: 2023-07-19
• Public Version Status: New
• Public Device Record Key: e9e68294-95af-47b2-b795-cbcbd117510e

Device Description

GFAP 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
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57240	Glial fibrillary acidic protein (GFAP) 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 glial fibrillary acidic protein (GFAP) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740194864	GS1

Customer Contacts

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

Storage Conditions

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