Alinity m

Basic Information

• Brand Name: Alinity m
• Primary DI: 00884999047716
• Version / Model: 09N20-004
• Catalog Number: 09N20-004
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-30
• Public Version: 6
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 3b7b7b01-56a2-4fb6-93db-4e15e9c5d808

Device Description

Alinity m Vapor Barrier Solution

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
OOI	real time Nucleic acid amplification system	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62690	Molecular grade procedure oil IVD	An inert oil (e.g., silicone oil, mineral oil, immersion oil) intended to be used as a barrier/seal/partitioning agent to minimize or prevent sample carryover and/or evaporation in an in vitro diagnostic assay performed on a clinical specimen (e.g., using a microwell plate), and/or to occupy the space between a microscope slide and a microscope objective lens to remove air and enhance image resolution of the microscope.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999047716	GS1

Customer Contacts

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

Storage Conditions

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