Unyvero

Basic Information

• Brand Name: Unyvero
• Primary DI: 04260364750041
• Version / Model: M1 Master Mix Tube Kit
• Catalog Number: 10020
• Company Name: Curetis GmbH
• Labeler DUNS: 312621863
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-28
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 9b301b58-8344-4835-af1d-498942e7622d

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QBH	Lower respiratory microbial nucleic acid detection system	Microbiology	866.3985	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60092	DNA amplification enzyme reagent IVD	A substance or reactant intended to be used as an enzyme in a molecular assay to facilitate the amplification of target deoxyribonucleic acid (DNA) in a clinical specimen, using a polymerase chain reaction (PCR) technique.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260364750041	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN170047	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: -20 Degrees Celsius