Alinity m

Basic Information

• Brand Name: Alinity m
• Primary DI: 00884999047464
• Version / Model: 09N26-016
• Catalog Number: 09N26-016
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-29
• Public Version: 1
• Public Version Date: 2020-05-07
• Public Version Status: New
• Public Device Record Key: f8ca1eb4-1b9b-49ca-93d3-e682f5a74337

Device Description

Alinity m Universal Sample Rack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
15186	Test tube rack	A non-sterile device designed to hold test tubes in an upright and secured position. It is typically made of metal and/or plastic and consists of a base plate upon which it stands and second plate containing a mesh (grid of square slots) or round holes which is supported at a given height with spacers or diving walls. It is typically used in a clinical laboratory. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999047464	GS1

Customer Contacts

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

Storage Conditions

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