Idylla™ Respiratory (IFV-RSV) Panel A1030/6

GUDID 15415219000635

Biocartis NV

Multiple respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 15415219000635
• NIH Device Record Key: 8e599c39-0e75-4adb-8dfb-38bf47bc727a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idylla™ Respiratory (IFV-RSV) Panel
• Version Model Number: 1.0
• Catalog Number: A1030/6
• Company DUNS: 400686169
• Company Name: Biocartis NV
• Device Count: 6
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	05415219000638 [Unit of Use]
GS1	15415219000635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163628

FDA Product Code

• OCC: Respiratory Virus Panel Nucleic Acid Assay System

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: 2018-11-23
• Device Publish Date: 2018-10-23

Devices Manufactured by Biocartis NV

• 15415219000758 - Idylla™ MSI Test: 2023-05-11 The Idylla MSI Test, for use on the Idylla System, uses formalin-fixed, paraffin embedded (FFPE) tissue sections of human CRC tu
• 15415219000635 - Idylla™ Respiratory (IFV-RSV) Panel: 2018-11-23
• 15415219000635 - Idylla™ Respiratory (IFV-RSV) Panel: 2018-11-23
• 05415219000119 - Idylla™ System: 2018-03-29 Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System.
• 05415219000126 - Idylla™ System: 2018-03-29 The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch