Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740150662
• Version / Model: 09P5620
• Catalog Number: 09P5620
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-27
• Public Version: 4
• Public Version Date: 2023-06-09
• Public Version Status: Update
• Public Device Record Key: 04a26c47-1ac8-4416-ae7d-d4d3f7953dba

Device Description

Alinity c Complement C3 Reagent Kit 300 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
CZW	COMPLEMENT C3, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53684	Complement components C3/C3c IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade components C3 and/or C3c in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740150662	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: 30 Degrees Celsius