Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740165505
• Version / Model: 04V3810
• Catalog Number: 04V3810
• Company Name: Abbott Ireland Diagnostics
• Labeler DUNS: 985307301
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-07
• Public Version: 1
• Public Version Date: 2019-06-17
• Public Version Status: New
• Public Device Record Key: d50a03dd-4fb6-4891-941a-daf6d3182b96

Device Description

Alinity i STAT CK-MB Controls

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
JJY	Multi-analyte controls, all kinds (assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44693	Creatine kinase myocardial isoenzyme (CKMB) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740165505	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 0 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: store below -10 CEL until first use