Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740137007
• Version / Model: 07P8004
• Catalog Number: 07P8004
• Company Name: Abbott Ireland Diagnostics
• Labeler DUNS: 985307301
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-16
• Public Version: 1
• Public Version Date: 2023-11-24
• Public Version Status: New
• Public Device Record Key: 7039e8bf-f849-470e-bdb3-c6e0b11bb26f

Device Description

Alinity h-series Retic reagent

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: Yes
• 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
GJH	STAIN, RETICULOCYTE	Hematology	864.1850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55862	Reticulocyte count IVD, kit, cell count	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen using a manual, semi-automated or automated cell count method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740137007	GS1

Customer Contacts

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

Storage Conditions

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