Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740165215
• Version / Model: 09P5520
• Catalog Number: 09P5520
• Company Name: ABBOTT LABORATORIES
• Labeler DUNS: 079226220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-27
• Public Version: 2
• Public Version Date: 2021-08-19
• Public Version Status: Update
• Public Device Record Key: 21bf9a91-723d-4f99-b8aa-9c2ed15e8927

Device Description

Alinity c Cocaine Reagent Kit 500 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
DIO	Enzyme immunoassay, cocaine and cocaine metabolites	Clinical Toxicology	862.3250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55562	Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites 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	00380740165215	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181499	000

Storage Conditions

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