AutoDELFIA Sample processor 1297-0110

GUDID 06438147334780

Used with 1235-5220 AutoDELFIA® System (SP and PP).

Wallac Oy

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 06438147334780
• NIH Device Record Key: 1a408461-7998-45ee-a8e1-b947e6d6208a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA Sample processor
• Version Model Number: 1297-0110
• Catalog Number: 1297-0110
• 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	06438147334780 [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: 2016-07-01

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