EZ2 Connect MDx 9003230

GUDID 04053228040576

The EZ2 Connect MDx is a compact benchtop instrument for automated isolation of nucleic acids from up to 24 samples in parallel, using sealed prefilled cartridges The EZ2 Connect MDx system is designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. The EZ2 Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the EZ2 Connect MDx instrument for the applications described in the kit handbooks. The EZ2 Connect MDx system is intended for use by professional operators, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ2 Connect MDx system.

QIAGEN GmbH

Specimen processing instrument IVD

• Primary Device ID: 04053228040576
• NIH Device Record Key: 2de8a189-e6db-4ce0-918d-5eb7c2f237e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ2 Connect MDx
• Version Model Number: 9003230
• Catalog Number: 9003230
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 30 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 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Altitude Up to 2000 m (6500 ft.)
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 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 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Altitude Up to 2000 m (6500 ft.)
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 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 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Altitude Up to 2000 m (6500 ft.)
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 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 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Altitude Up to 2000 m (6500 ft.)
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 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 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Altitude Up to 2000 m (6500 ft.)
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 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 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Altitude Up to 2000 m (6500 ft.)
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 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 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Altitude Up to 2000 m (6500 ft.)
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 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 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Altitude Up to 2000 m (6500 ft.)
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 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 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Altitude Up to 2000 m (6500 ft.)
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 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 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Altitude Up to 2000 m (6500 ft.)

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228040576 [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: 2026-03-11
• Device Publish Date: 2026-03-03

Devices Manufactured by QIAGEN GmbH

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