Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740129590
• Version / Model: 08P7901
• Catalog Number: 08P7901
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-16
• Public Version: 2
• Public Version Date: 2024-02-14
• Public Version Status: Update
• Public Device Record Key: b37a7e29-1c9f-45b4-af16-864f3e6c8d2e

Device Description

Alinity h-series Smear Fix

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
LDZ	FIXATIVE, ALCOHOL CONTAINING	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57724	Reagent grade alcohol solution IVD	A reagent grade alcohol solution (e.g., methanol, ethanol, isopropanol) intended to be used as a dehydrant in the processing of biological tissues or clinical specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740129590	GS1

Customer Contacts

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

Storage Conditions

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