Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740155292
• Version / Model: 04T8230
• Catalog Number: 04T8230
• Company Name: ABBOTT IRELAND
• Labeler DUNS: 989964119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-15
• Public Version: 3
• Public Version Date: 2025-08-18
• Public Version Status: Update
• Public Device Record Key: 51ee9ed2-0ac5-4d45-a2ba-8a5975ab75a5

Device Description

Albumin BCP2 2200 Tests

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: 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
CJW	BROMCRESOL PURPLE DYE-BINDING, ALBUMIN	Clinical Chemistry	862.1035	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59071	Albumin IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a spectrophotometry method. It is typically used to aid in the diagnosis and monitoring of diseases affecting protein metabolism (e.g., liver disease, kidney disease, severe malnutrition, malabsorption, burns).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740155292	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius