AccessGUDID - DEVICE: Unyvero (04260364750041)

GUDID

Device Identifier (DI) Information

Brand Name: Unyvero
Version or Model: M1 Master Mix Tube Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10020
Company Name: Curetis GmbH

Primary DI Number: 04260364750041
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 312621863 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QBH	Lower respiratory microbial nucleic acid detection system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9b301b58-8344-4835-af1d-498942e7622d
Public Version Date: February 03, 2025
Public Version Number: 3
DI Record Publish Date: May 28, 2018