Unyvero

Basic Information

• Brand Name: Unyvero
• Primary DI: 04260364750034
• Version / Model: LRT Cartridge Kit
• Catalog Number: 10049
• 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: 29d9d2a2-ee14-43ee-aae2-d269d0378d08

Device Description

Kit of 12 disposable Unyvero LRT 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)

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
60764	Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple bacteria associated with respiratory disease in a clinical specimen, and/or one or multiple genes conferring antimicrobial resistance in the respiratory isolates detected, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila psittaci, C. pneumoniae (Chlamydia pneumoniae), Coxiella burnetii, Legionella pneumophila and/or Bordetella pertussis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260364750034	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN170047	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius