AutoDELFIA Automatic Immunoassay System 1235-5110

GUDID 06438147335008

The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid in screening with associated AutoDELFIA® reagent kits for neonatal screening and prenatal screening. It is an automatic immunoassay system designed to automatically perform assays using the proven and widely used method of time-resolved fluorometry. It is intended for in vitro quantitative determination of analytes as described by the associated assays. The function, specific disorder, condition or risk factor to be identified, the specimen type, and testing population are based on and described within the intended purpose of the applicable assay. The AutoDELFIA® system is intended to be used by trained laboratory personnel.

Wallac Oy

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 06438147335008
• NIH Device Record Key: a2c36297-3018-46aa-a5ea-ff3f16ccd6b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoDELFIA Automatic Immunoassay System
• Version Model Number: 1235-5110
• Catalog Number: 1235-5110
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147335008 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-19
• Device Publish Date: 2022-08-11

On-Brand Devices [AutoDELFIA Automatic Immunoassay System]

• 06438147335022: The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid
• 06438147335008: The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid