Unyvero

Primary DI
04260364750027
Brand
Unyvero
Company
Curetis GmbH
Model
C8 Cockpit
Catalog number
60003
Device description
User interface and instrument to control Unyvero Application workflow in combination with Unyvero L4 Lysator(s) and Unyvero A50 Analyzer(s)
Published
2018-05-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QBHLower respiratory microbial nucleic acid detection system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBHLower Respiratory Microbial Nucleic Acid Detection SystemMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260364750027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260364750027042603647500274260364750027

GMDN Terms#

Term, Definition table
TermDefinition
Clinical laboratory analyser/instrument control unit IVDAn electrically-powered device intended to be used to control one or multiple in vitro diagnostic laboratory analyser(s)/instrument(s) used in the processing/preparation/analysis of a clinical specimen. It is designed to enable the user to input/manipulate sample data and select assays to be performed. The device consists of a combination of dedicated and off-the-shelf hardware [e.g., personal computer (PC), keyboard mouse and/or graphical user interface (GUI) touchscreen monitor] and software. It may include network components for the management and distribution of associated medical data (e.g., images, test results, patient-specific data) within or between healthcare facilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(619)452-3644support_us@curetis.com

Regulatory Flags#

DUNS number
312621863
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260364751017AcuitasCuretis Qualified QuantStudio™ 5 Real-Time PCR Sys620062023-04-17
04260364750003UnyveroA50 Analyzer600012018-05-28
04260364751031AcuitasAcuitas AMR Gene Panel Reagent Kit120022023-03-15
04260364750058UnyveroLRT BAL Cartridge Kit100912020-01-15
04260364750010UnyveroL4 Lysator600022018-05-28
04260364750034UnyveroLRT Cartridge Kit100492018-05-28
04260364750041UnyveroM1 Master Mix Tube Kit100202018-05-28
04260364751000AcuitasQIAGEN® EZ1® Advanced XL System620052023-04-17
04260364751024AcuitasAcuitas AMR Gene Panel PCR Plate Kit120012023-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260364750058UnyveroCuretis GmbHQBH2020-01-15
00815381020178FilmArray® Pneumonia Panel (Pneumo)BIOFIRE DIAGNOSTICS, LLCQBH2018-12-12
00815381020185FilmArray® Pneumonia Panel (Pneumo)BIOFIRE DIAGNOSTICS, LLCQBH2018-12-12
04260364750003UnyveroCuretis GmbHQBH2018-05-28
04260364750010UnyveroCuretis GmbHQBH2018-05-28
04260364750034UnyveroCuretis GmbHQBH2018-05-28
04260364750041UnyveroCuretis GmbHQBH2018-05-28