QIAstat-Dx® Respiratory Panel 691221

GUDID 04053228033905

QIAGEN GmbH

Multiple 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

Devices Manufactured by QIAGEN GmbH

• 04053228003526 - QIAGEN Buffer ASL®: 2024-10-08 Stool Lysis Buffer
• 04053228048268 - QIAsymphony® DSP Circulating DNA Maxi Kit (192): 2024-10-08
• 04053228048350 - QIAsymphony® DSP Circulating DNA Kit (96): 2024-10-08
• 04053228048770 - QIAcuityDx® Four: 2024-10-08 The QIAcuityDx® Four is an automated digital PCR (dPCR) instrument designed to perform amplification, detection (qualitative an
• 04053228049418 - QIAcuityDx® Universal MasterMix Kit: 2024-10-08 The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityD
• 04053228049432 - QIAcuityDx® Universal MasterMix Kit: 2024-10-08 The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityD
• 04053228049685 - QIAcuityDx® Nanoplate 26k 24-well: 2024-10-08 The QIAcuity® Nanoplate 26k 24-well is a single use disposable that partitions samples and reaction mixes using a microfluidic
• 04053228047582 - QIAstat-Dx Analyzer 2.0: 2024-09-26 The QIAstat-Dx Analyzer 2.0 platform is intended as an in vitro diagnostic device for use with QIAstat-Dx assays and provides fu