AutoDELFIA Sample Processor 1297-014

GUDID 06438147116157

Used with 1235-514 Fully Automatic DELFIA® System

Wallac Oy

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 06438147116157
• NIH Device Record Key: ffc68955-fde3-40c9-bd19-e411f54327b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA Sample Processor
• Version Model Number: 1297-014
• Catalog Number: 1297-014
• 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	06438147116157 [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 Sample Processor]

• 06438147334780: Used with 1235-5220 AutoDELFIA® System (SP and PP).
• 06438147116157: Used with 1235-514 Fully Automatic DELFIA® System