DELFIA Enhancement Solution

Basic Information

• Brand Name: DELFIA Enhancement Solution
• Primary DI: 06438147005253
• Version / Model: 1244-104
• Catalog Number: 1244-104
• 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: 1
• Public Version Date: 2018-12-17
• Public Version Status: New
• Public Device Record Key: 04581d88-1ac6-4f4b-9d9a-f130fd36ac87

Device Description

For the quantitative determination of europium (Eu³⁺) and samarium (Sm³⁺) in dissociation-enhanced time-resolved fluoroimmunoassays.

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
58775	Fluorescent immunoassay dissociation-enhancement reagent IVD	A substance or reactant intended to be used when performing a time-resolved fluorescent immunoassay on a clinical specimen to enhance and/or optimise the signal by dissociating the fluorescent label from antigen or antibody bound in the solid phase and inducing the formation of highly detectable chelates in solution.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147005253	GS1

Storage Conditions

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