Unyvero 10091

GUDID 04260364750058

Kit of 12 disposable Unyvero LRT BAL Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit)

Curetis GmbH

Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique

• Primary Device ID: 04260364750058
• NIH Device Record Key: ccecb2a2-9930-43fb-8492-b993ae5a891f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unyvero
• Version Model Number: LRT BAL Cartridge Kit
• Catalog Number: 10091
• 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 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260364750058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191967

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: 1
• Public Version Date: 2020-01-23
• Device Publish Date: 2020-01-15

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