AutoDELFIA Plate Processor 1235-001

GUDID 06438147116133

Used with 1235-501 AutoDELFIA® Plate Processor System or 1235-514 Fully Automatic DELFIA® System

Wallac Oy

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 06438147116133
• NIH Device Record Key: 7f491669-fad1-492d-838e-3ecfbfef61cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA Plate Processor
• Version Model Number: 1235-001
• Catalog Number: 1235-001
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147116133 [Primary]

FDA Product Code

• KHO: Fluorometer, For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-24

On-Brand Devices [AutoDELFIA Plate Processor]

• 06438147334766: Used with 1235-5110 AutoDELFIA® Plate Processor System or 1235-5220 AutoDELFIA® System (SP and
• 06438147116133: Used with 1235-501 AutoDELFIA® Plate Processor System or 1235-514 Fully Automatic DELFIA® Syst