QIAstat-Dx® Rise 9003163

GUDID 04053228041849

The QIAstat-Dx Rise system is intended as an in-vitro diagnostic device for use with QIAstat-Dx in-vitro diagnostic assays indicated for use with QIAstat-Dx Rise and provides full automation from sample preparation to real-time PCR detection for molecular applications. The system is designed for professional use only and it is not a device for self-testing or near-patient testing.

QIAGEN GmbH

Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 04053228041849
• NIH Device Record Key: 1ae972a4-fa3b-4fa3-b4df-1b41d0a665a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QIAstat-Dx® Rise
• Version Model Number: 1
• Catalog Number: 9003163
• Company DUNS: 317103745
• Company Name: QIAGEN GmbH
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com
• Phone: 8003627737
• Email: techservice-na@qiagen.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228041849 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-15
• Device Publish Date: 2025-09-05

Devices Manufactured by QIAGEN GmbH

• 04053228041849 - QIAstat-Dx® Rise: 2025-09-15The QIAstat-Dx Rise system is intended as an in-vitro diagnostic device for use with QIAstat-Dx in-vitro diagnostic assays indicated for use with QIAstat-Dx Rise and provides full automation from sample preparation to real-time PCR detection for molecular applications. The system is designed for professional use only and it is not a device for self-testing or near-patient testing.
• 04053228041849 - QIAstat-Dx® Rise: 2025-09-15 The QIAstat-Dx Rise system is intended as an in-vitro diagnostic device for use with QIAstat-Dx in-vitro diagnostic assays indic
• 04053228035725 - therascreen® BRAF RGQ PCR Kit: 2025-06-09 The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene
• 04053228048381 - QIAstat-Dx® GI Panel 2 Mini B: 2025-04-07
• 04053228049166 - QIAstat-Dx® GI Panel 2 Mini B&V: 2025-02-26
• 04053228048862 - QIAstat-Dx® Respiratory Panel Mini: 2024-12-13
• 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