FDA.reportPublic FDA data

Unyvero

Primary DI
04260364750010
Brand
Unyvero
Company
Curetis GmbH
Model
L4 Lysator
Catalog number
60002
Device description
Instrument to pre-process up to 4 samples for Unyvero Cartridges
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
04260364750010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260364750010042603647500104260364750010

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sample preparation instrument IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification. The device operates with minimal technician involvement and complete automation of all procedural steps.

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
04260364750027UnyveroC8 Cockpit600032018-05-28
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
04260364750027UnyveroCuretis GmbHQBH2018-05-28
04260364750034UnyveroCuretis GmbHQBH2018-05-28
04260364750041UnyveroCuretis GmbHQBH2018-05-28