QIAcuityDx® Nanoplate 26k 24-well 260001

GUDID 04053228049685

The QIAcuity® Nanoplate 26k 24-well is a single use disposable that partitions samples and reaction mixes using a microfluidic plate-based technology to enable the QIAcuityDx® Four to be used as intended. The QIAcuity® Nanoplate 26k 24-well is used in conjunction with the QIAcuity® Nanoplate Seals, QIAcuity® Nanoplate Tray, and the QIAcuity® Roller to establish a closure to allow air displacement to push samples into the partitioning area of the QIAcuity® Nanoplate 26k 24-well during priming. The QIAcuity® Nanoplate 26k 24-well is intended for in vitro diagnostic use. The QIAcuityDx Nanoplate is not an automated device.

QIAGEN GmbH

Microplate IVD

• Primary Device ID: 04053228049685
• NIH Device Record Key: 53f08fa2-aedd-4767-b4eb-67babbba6e5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QIAcuityDx® Nanoplate 26k 24-well
• Version Model Number: 1
• Catalog Number: 260001
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Phone: 8003627737
• Email: techservice-na@qiagen.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228049685 [Primary]

FDA Product Code

• PHG: Droplet Digital Pcr 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: 2024-10-08
• Device Publish Date: 2024-09-30

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• 04053228049685 - QIAcuityDx® Nanoplate 26k 24-well: 2024-10-08The QIAcuity® Nanoplate 26k 24-well is a single use disposable that partitions samples and reaction mixes using a microfluidic plate-based technology to enable the QIAcuityDx® Four to be used as intended. The QIAcuity® Nanoplate 26k 24-well is used in conjunction with the QIAcuity® Nanoplate Seals, QIAcuity® Nanoplate Tray, and the QIAcuity® Roller to establish a closure to allow air displacement to push samples into the partitioning area of the QIAcuity® Nanoplate 26k 24-well during priming. The QIAcuity® Nanoplate 26k 24-well is intended for in vitro diagnostic use. The QIAcuityDx Nanoplate is not an automated device.
• 04053228049685 - QIAcuityDx® Nanoplate 26k 24-well: 2024-10-08 The QIAcuity® Nanoplate 26k 24-well is a single use disposable that partitions samples and reaction mixes using a microfluidic