QIAcube Connect MDx 9003070

GUDID 04053228039129

The QIAcube Connect MDx system is a fully automated, sample preparation system, processing up to 12 samples using silica spin columns technology. The QIAcube Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the QIAcube Connect MDx system for the protocols described in the instructions for use of the respective kits. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAcube Connect IVD system.

QIAGEN GmbH

Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD

• Primary Device ID: 04053228039129
• NIH Device Record Key: 02fa965e-e5bb-45f7-9bd3-3a3459f4a9eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QIAcube Connect MDx
• Version Model Number: 1
• Catalog Number: 9003070
• 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: 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
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228039129 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

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: 2022-09-08
• Device Publish Date: 2022-08-31

Devices Manufactured by QIAGEN GmbH

• 04053228043249 - QIAstat-Dx® Gastrointestinal Panel 2: 2024-06-25
• 04053228047438 - QIAstat-Dx® Respiratory Panel Plus: 2024-06-25
• 04053228030072 - QIAsymphony® DSP Circulating DNA Kit: 2022-12-15
• 04053228031024 - RNeasy® DSP FFPE Kit: 2022-12-15
• 04053228045762 - QIAsymphony® DSP DNA Midi Kit: 2022-12-15
• 04053228045779 - QIAsymphony® DSP DNA Mini Kit: 2022-12-15
• 04053228045786 - QIAsymphony® DSP Virus/Pathogen Midi Kit: 2022-12-15
• 04053228045793 - QIAsymphony® DSP Virus/Pathogen Mini Kit: 2022-12-15