Idylla™ System P0010

GUDID 05415219000119

Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System.

Biocartis NV

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 05415219000119
• NIH Device Record Key: d94af444-ec09-42a6-b587-cbbbfdcb5344
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idylla™ System
• Version Model Number: Idylla™ Instrument
• Catalog Number: P0010
• Company DUNS: 400686169
• Company Name: Biocartis NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	05415219000119 [Primary]

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification System

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: 2017-08-21

On-Brand Devices [Idylla™ System]

• 05415219000126: The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader
• 05415219000119: Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System.