Unyvero 60003

GUDID 04260364750027

User interface and instrument to control Unyvero Application workflow in combination with Unyvero L4 Lysator(s) and Unyvero A50 Analyzer(s)

Curetis GmbH

Clinical laboratory analyser/instrument control unit IVD
Primary Device ID04260364750027
NIH Device Record Keyf957d17a-83e4-4478-bf7d-60d30f874149
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnyvero
Version Model NumberC8 Cockpit
Catalog Number60003
Company DUNS312621863
Company NameCuretis GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com
Phone+1(619)452-3644
Emailsupport_us@curetis.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104260364750027 [Primary]

FDA Product Code

QBHLower respiratory microbial nucleic acid detection system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-09-12
Device Publish Date2018-05-28

On-Brand Devices [Unyvero]

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

Trademark Results [Unyvero]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNYVERO
UNYVERO
85068577 4309449 Live/Registered
CURETIS GMBH
2010-06-22

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