QIAstat-Dx® Respiratory Panel 691221

GUDID 04053228033905

QIAGEN GmbH

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

• Primary Device ID: 04053228033905
• NIH Device Record Key: b06cbff6-fc22-4b51-a491-78d026ff588b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QIAstat-Dx® Respiratory Panel
• Version Model Number: V1
• Catalog Number: 691221
• Company DUNS: 317103745
• Company Name: QIAGEN GmbH
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228033905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183597

FDA Product Code

• OZZ: Bordetella Pertussis Dna Assay 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: 2019-10-28
• Device Publish Date: 2019-05-24

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• 04053228045793 - QIAsymphony® DSP Virus/Pathogen Mini Kit: 2022-12-15