DELFIA Diluent II B138-100

GUDID 06438147119158

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

Wallac Oy

Buffered sample diluent IVD, automated/semi-automated system

• Primary Device ID: 06438147119158
• NIH Device Record Key: a04cff4b-6c1c-4acb-83ee-e50e103db56c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELFIA Diluent II
• Version Model Number: B138-100
• Catalog Number: B138-100
• Company DUNS: 540156544
• Company Name: Wallac Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147119158 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-11-16

On-Brand Devices [DELFIA Diluent II]

• 06438147119158: For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.
• 06438147009770: For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.
• 06438147009763: For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.