Unyvero

Primary DI
04260364750041
Brand
Unyvero
Company
Curetis GmbH
Model
M1 Master Mix Tube Kit
Catalog number
10020
Device description
Kit of 12 Unyvero M1 Master Mix Tubes, to be used with Unyvero LRT 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
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170047000Curetis Unyvero LRT ApplicationCuretis GmbH2018-04-03QBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260364750041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260364750041042603647500414260364750041

GMDN Terms#

Term, Definition table
TermDefinition
DNA amplification enzyme reagent IVDA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0-20 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
Kit
true
Lot or batch
true
Expiration date on label
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
04260364750027UnyveroC8 Cockpit600032018-05-28
04260364750034UnyveroLRT Cartridge Kit100492018-05-28
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
04260364750027UnyveroCuretis GmbHQBH2018-05-28
04260364750034UnyveroCuretis GmbHQBH2018-05-28