Unyvero 10020

GUDID 04260364750041

Kit of 12 Unyvero M1 Master Mix Tubes, to be used with Unyvero LRT Cartridges

Curetis GmbH

DNA amplification enzyme reagent IVD

• Primary Device ID: 04260364750041
• NIH Device Record Key: 9b301b58-8344-4835-af1d-498942e7622d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unyvero
• Version Model Number: M1 Master Mix Tube Kit
• Catalog Number: 10020
• Company DUNS: 312621863
• Company Name: Curetis GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(619)452-3644
• Email: support_us@curetis.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260364750041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170047

FDA Product Code

• QBH: Lower respiratory microbial nucleic acid detection 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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-28

On-Brand Devices [Unyvero]

• 04260364750041: Kit of 12 Unyvero M1 Master Mix Tubes, to be used with Unyvero LRT Cartridges
• 04260364750034: Kit of 12 disposable Unyvero LRT Cartridges, including sample tubes, sample tube caps and sample
• 04260364750027: User interface and instrument to control Unyvero Application workflow in combination with Unyver
• 04260364750010: Instrument to pre-process up to 4 samples for Unyvero Cartridges
• 04260364750003: Instrument to process 2 Unyvero Cartridges
• 04260364750058: Kit of 12 disposable Unyvero LRT BAL Cartridges, including sample tubes, sample tube caps and sa