QIAstat-Dx Analyzer 2.0 9002828

GUDID 04053228047582

The QIAstat-Dx Analyzer 2.0 platform is intended as an in vitro diagnostic device for use with QIAstat-Dx assays and provides full automation from sample preparation to real-time PCR detection for molecular applications.

QIAGEN GmbH

Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 04053228047582
• NIH Device Record Key: b7b362c2-30e2-48a5-a906-4507c63a997e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QIAstat-Dx Analyzer 2.0
• Version Model Number: 1
• Catalog Number: 9002828
• 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
• 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
• 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	04053228047582 [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: 2024-09-26
• Device Publish Date: 2024-09-18

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