Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740135324
• Version / Model: 08P3720
• Catalog Number: 08P3720
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 079226220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-04
• Public Version: 3
• Public Version Date: 2023-09-06
• Public Version Status: Update
• Public Device Record Key: 6e174192-a0a1-474f-a58e-22b73a235d7b

Device Description

Alinity c Digoxin Reagent Kit 800 Tests

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: No
• 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
KXT	ENZYME IMMUNOASSAY, DIGOXIN	Clinical Toxicology	862.3320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55324	Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug digoxin in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740135324	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023058	000

Storage Conditions

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