DELFIA Diluent 3

Basic Information

• Brand Name: DELFIA Diluent 3
• Primary DI: 06438147244898
• Version / Model: 4022-0010
• Catalog Number: 4022-0010
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-16
• Public Version: 2
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 4ca665bc-7ebc-469c-9849-9075b04e7ee1

Device Description

For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.

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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147244898	GS1

Storage Conditions

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