Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740165314
• Version / Model: 08P6301
• Catalog Number: 08P6301
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 079226220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-12
• Public Version: 1
• Public Version Date: 2019-09-20
• Public Version Status: New
• Public Device Record Key: 0f2e7a86-2358-4c78-a50e-f77e18169b32

Device Description

Alinity c DOA MC Qual Low Calibrator 1 Kit

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: 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
DKB	Calibrators, drug mixture	Clinical Toxicology	862.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55460	Multiple drugs of abuse IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740165314	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius