QIAensemble Decapper System 9001923

GUDID 04053228003519

QIAGEN GmbH

Nucleic acid sample preparation instrument IVD, automated

• Primary Device ID: 04053228003519
• NIH Device Record Key: 81d03eca-042d-4b0d-923f-e6f92e15cbc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QIAensemble Decapper System
• Version Model Number: 1
• Catalog Number: 9001923
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228003519 [Primary]

FDA Product Code

• JQW: Station, Pipetting And Diluting, For Clinical Use

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: 2018-03-29
• Device Publish Date: 2017-08-15

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• 04053228048862 - QIAstat-Dx® Respiratory Panel Mini: 2024-12-13
• 04053228003526 - QIAGEN Buffer ASL®: 2024-10-08 Stool Lysis Buffer
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